Application 208799
- Type
- NDA
- Sponsor
- TEVA PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | POWDER;INHALATION | 0.055MG/INH;EQ 0.014MG BASE/INH | Yes | No |
| 002 | AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | POWDER;INHALATION | 0.113MG/INH;EQ 0.014MG BASE/INH | Yes | No |
| 003 | AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | POWDER;INHALATION | 0.232MG/INH;EQ 0.014MG BASE/INH | Yes | Yes |
| 004 | AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | POWDER;INHALATION | 0.055MG/INH;EQ 0.014MG BASE/INH | Yes | No |
| 005 | AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | POWDER;INHALATION | 0.113MG/INH;EQ 0.014MG BASE/INH | Yes | No |
| 006 | AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | POWDER;INHALATION | 0.232MG/INH;EQ 0.014MG BASE/INH | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208799-001 | AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | |
| N208799-002 | AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | |
| N208799-003 | AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | |
| N208799-004 | AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | |
| N208799-005 | AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | |
| N208799-006 | AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208799-001 | 10195375 | 2031-02-14 | Drug product | 2019-03-05 | |
| N208799-001 | 10195375*PED | 2031-08-14 | Pediatric extension | ||
| N208799-001 | 9066957 | 2034-10-06 | U-645 | Drug product | 2017-01-30 |
| N208799-001 | 9415008 | 2034-10-06 | U-645 | Drug product | 2017-01-30 |
| N208799-001 | 9066957*PED | 2035-04-06 | Pediatric extension | ||
| N208799-001 | 9415008*PED | 2035-04-06 | Pediatric extension | ||
| N208799-001 | 11969544 | 2039-08-20 | Drug product | 2024-05-29 | |
| N208799-001 | 11969544*PED | 2040-02-20 | Pediatric extension | ||
| N208799-002 | 10195375 | 2031-02-14 | Drug product | 2019-03-05 | |
| N208799-002 | 10195375*PED | 2031-08-14 | Pediatric extension | ||
| N208799-002 | 9066957 | 2034-10-06 | U-645 | Drug product | 2017-01-30 |
| N208799-002 | 9066957*PED | 2035-04-06 | Pediatric extension | ||
| N208799-002 | 11969544 | 2039-08-20 | Drug product | 2024-05-29 | |
| N208799-002 | 11969544*PED | 2040-02-20 | Pediatric extension | ||
| N208799-003 | 10195375 | 2031-02-14 | Drug product | 2019-03-05 | |
| N208799-003 | 10195375*PED | 2031-08-14 | Pediatric extension | ||
| N208799-003 | 9066957 | 2034-10-06 | U-645 | Drug product | 2017-01-30 |
| N208799-003 | 9066957*PED | 2035-04-06 | Pediatric extension | ||
| N208799-003 | 11969544 | 2039-08-20 | Drug product | 2024-05-29 | |
| N208799-003 | 11969544*PED | 2040-02-20 | Pediatric extension | ||
| N208799-004 | 10195375 | 2031-02-14 | Drug product | 2019-08-02 | |
| N208799-004 | 10195375*PED | 2031-08-14 | Pediatric extension | ||
| N208799-004 | 9066957 | 2034-10-06 | U-645 | Drug product | 2019-08-02 |
| N208799-004 | 9415008 | 2034-10-06 | U-645 | Drug product | 2019-08-02 |
| N208799-004 | 9066957*PED | 2035-04-06 | Pediatric extension | ||
| N208799-004 | 9415008*PED | 2035-04-06 | Pediatric extension | ||
| N208799-004 | 10918816 | 2035-12-14 | Drug product | 2021-03-18 | |
| N208799-004 | 10918816*PED | 2036-06-14 | Pediatric extension | ||
| N208799-004 | 11969544 | 2039-08-20 | Drug product | 2024-05-29 | |
| N208799-004 | 11344685 | 2039-09-26 | Drug product | 2022-06-29 | |
| N208799-004 | 11969544*PED | 2040-02-20 | Pediatric extension | ||
| N208799-004 | 11344685*PED | 2040-03-26 | Pediatric extension | ||
| N208799-004 | 11173259 | 2040-07-06 | Drug product | 2021-12-08 | |
| N208799-004 | 11173259*PED | 2041-01-06 | Pediatric extension | ||
| N208799-005 | 10195375 | 2031-02-14 | Drug product | 2019-08-02 | |
| N208799-005 | 10195375*PED | 2031-08-14 | Pediatric extension | ||
| N208799-005 | 9066957 | 2034-10-06 | U-645 | Drug product | 2019-08-02 |
| N208799-005 | 9066957*PED | 2035-04-06 | Pediatric extension | ||
| N208799-005 | 10918816 | 2035-12-14 | Drug product | 2021-03-18 | |
| N208799-005 | 10918816*PED | 2036-06-14 | Pediatric extension | ||
| N208799-005 | 11969544 | 2039-08-20 | Drug product | 2024-05-29 | |
| N208799-005 | 11344685 | 2039-09-26 | Drug product | 2022-06-29 | |
| N208799-005 | 11969544*PED | 2040-02-20 | Pediatric extension | ||
| N208799-005 | 11344685*PED | 2040-03-26 | Pediatric extension | ||
| N208799-005 | 11173259 | 2040-07-06 | Drug product | 2021-12-08 | |
| N208799-005 | 11173259*PED | 2041-01-06 | Pediatric extension | ||
| N208799-006 | 10195375 | 2031-02-14 | Drug product | 2019-08-02 | |
| N208799-006 | 10195375*PED | 2031-08-14 | Pediatric extension | ||
| N208799-006 | 9066957 | 2034-10-06 | U-645 | Drug product | 2019-08-02 |
| N208799-006 | 9066957*PED | 2035-04-06 | Pediatric extension | ||
| N208799-006 | 10918816 | 2035-12-14 | Drug product | 2021-03-18 | |
| N208799-006 | 10918816*PED | 2036-06-14 | Pediatric extension | ||
| N208799-006 | 11969544 | 2039-08-20 | Drug product | 2024-05-29 | |
| N208799-006 | 11344685 | 2039-09-26 | Drug product | 2022-06-29 | |
| N208799-006 | 11969544*PED | 2040-02-20 | Pediatric extension | ||
| N208799-006 | 11344685*PED | 2040-03-26 | Pediatric extension | ||
| N208799-006 | 11173259 | 2040-07-06 | Drug product | 2021-12-08 | |
| N208799-006 | 11173259*PED | 2041-01-06 | Pediatric extension |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N208799-001 | AIRDUO RESPICLICK | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-002 | AIRDUO RESPICLICK | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-003 | AIRDUO RESPICLICK | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | AIRDUO DIGIHALER | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-005 | AIRDUO DIGIHALER | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-006 | AIRDUO DIGIHALER | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208799-001 | AIRDUO RESPICLICK | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208799-002 | AIRDUO RESPICLICK | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208799-003 | AIRDUO RESPICLICK | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208799-004 | AIRDUO DIGIHALER | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208799-005 | AIRDUO DIGIHALER | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208799-006 | AIRDUO DIGIHALER | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208799-001 | AIRDUO RESPICLICK | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208799-002 | AIRDUO RESPICLICK | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208799-003 | AIRDUO RESPICLICK | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208799-004 | AIRDUO DIGIHALER | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208799-005 | AIRDUO DIGIHALER | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208799-006 | AIRDUO DIGIHALER | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208799-001 | AIRDUO RESPICLICK | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208799-002 | AIRDUO RESPICLICK | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208799-003 | AIRDUO RESPICLICK | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208799-004 | AIRDUO DIGIHALER | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208799-005 | AIRDUO DIGIHALER | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208799-006 | AIRDUO DIGIHALER | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208799-001 | AIRDUO RESPICLICK | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208799-002 | AIRDUO RESPICLICK | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208799-003 | AIRDUO RESPICLICK | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208799-004 | AIRDUO DIGIHALER | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208799-005 | AIRDUO DIGIHALER | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208799-006 | AIRDUO DIGIHALER | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208799-001 | AIRDUO RESPICLICK | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208799-002 | AIRDUO RESPICLICK | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208799-003 | AIRDUO RESPICLICK | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208799-004 | AIRDUO DIGIHALER | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208799-005 | AIRDUO DIGIHALER | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208799-006 | AIRDUO DIGIHALER | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208799-001 | AIRDUO RESPICLICK | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208799-002 | AIRDUO RESPICLICK | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2017-01-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208799-003 | AIRDUO RESPICLICK | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD, RS | 2017-01-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208799-004 | AIRDUO DIGIHALER | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER / INHALATION | RLD | 2019-07-12 | 2680178bc6a6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N208799-001 | 10195375 | 2031-02-14 | Drug product | 2019-03-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-001 | 10195375*PED | 2031-08-14 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-001 | 9066957 | 2034-10-06 | U-645 | Drug product | 2017-01-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-001 | 9415008 | 2034-10-06 | U-645 | Drug product | 2017-01-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-001 | 9066957*PED | 2035-04-06 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-001 | 9415008*PED | 2035-04-06 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-001 | 11969544 | 2039-08-20 | Drug product | 2024-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-001 | 11969544*PED | 2040-02-20 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-002 | 10195375 | 2031-02-14 | Drug product | 2019-03-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-002 | 10195375*PED | 2031-08-14 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-002 | 9066957 | 2034-10-06 | U-645 | Drug product | 2017-01-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-002 | 9066957*PED | 2035-04-06 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-002 | 11969544 | 2039-08-20 | Drug product | 2024-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-002 | 11969544*PED | 2040-02-20 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-003 | 10195375 | 2031-02-14 | Drug product | 2019-03-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-003 | 10195375*PED | 2031-08-14 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-003 | 9066957 | 2034-10-06 | U-645 | Drug product | 2017-01-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-003 | 9066957*PED | 2035-04-06 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-003 | 11969544 | 2039-08-20 | Drug product | 2024-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-003 | 11969544*PED | 2040-02-20 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 10195375 | 2031-02-14 | Drug product | 2019-08-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 10195375*PED | 2031-08-14 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 9066957 | 2034-10-06 | U-645 | Drug product | 2019-08-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 9415008 | 2034-10-06 | U-645 | Drug product | 2019-08-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 9066957*PED | 2035-04-06 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 9415008*PED | 2035-04-06 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 10918816 | 2035-12-14 | Drug product | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 10918816*PED | 2036-06-14 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 11969544 | 2039-08-20 | Drug product | 2024-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 11344685 | 2039-09-26 | Drug product | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 11969544*PED | 2040-02-20 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 11344685*PED | 2040-03-26 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 11173259 | 2040-07-06 | Drug product | 2021-12-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-004 | 11173259*PED | 2041-01-06 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-005 | 10195375 | 2031-02-14 | Drug product | 2019-08-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-005 | 10195375*PED | 2031-08-14 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-005 | 9066957 | 2034-10-06 | U-645 | Drug product | 2019-08-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-005 | 9066957*PED | 2035-04-06 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208799-005 | 10918816 | 2035-12-14 | Drug product | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208799-005 | 10918816*PED | 2036-06-14 | Pediatric extension | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208799-001 | M-61 | 2024-07-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208799-001 | PED | 2025-01-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208799-004 | M-61 | 2024-07-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208799-004 | PED | 2025-01-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N208799-001 | M-61 | 2024-07-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208799-001 | PED | 2025-01-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208799-004 | M-61 | 2024-07-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208799-004 | PED | 2025-01-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208799-001 | M-61 | 2024-07-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208799-001 | PED | 2025-01-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208799-004 | M-61 | 2024-07-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208799-004 | PED | 2025-01-09 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208799-001 | M-61 | 2024-07-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208799-001 | PED | 2025-01-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208799-004 | M-61 | 2024-07-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208799-004 | PED | 2025-01-09 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208799-001 | M-61 | 2024-07-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208799-001 | PED | 2025-01-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208799-004 | M-61 | 2024-07-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208799-004 | PED | 2025-01-09 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208799-001 | M-61 | 2024-07-09 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208799-001 | PED | 2025-01-09 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208799-004 | M-61 | 2024-07-09 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208799-004 | PED | 2025-01-09 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208799-001 | M-61 | 2024-07-09 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208799-001 | PED | 2025-01-09 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208799-004 | M-61 | 2024-07-09 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208799-004 | PED | 2025-01-09 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208799-001 | M-61 | 2024-07-09 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208799-001 | PED | 2025-01-09 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208799-004 | M-61 | 2024-07-09 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208799-004 | PED | 2025-01-09 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N208799-001 | M-61 | 2024-07-09 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208799-001 | PED | 2025-01-09 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208799-004 | M-61 | 2024-07-09 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208799-004 | PED | 2025-01-09 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208799-001 | M-61 | 2024-07-09 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208799-001 | PED | 2025-01-09 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208799-004 | M-61 | 2024-07-09 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208799-004 | PED | 2025-01-09 | 79d66fd596c7… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fluticasone Propionate and Salmeterol | FLUTICASONE PROPIONATE AND SALMETEROL | Bryant Ranch Prepack | f3bce31d-93f9-4ca6-835e-b16e2d31b6c5 | 2025-08-21 | Warnings, Adverse reactions | 208799 NDA208799 |
| Fluticasone Propionate and Salmeterol | FLUTICASONE PROPIONATE AND SALMETEROL | Bryant Ranch Prepack | 038db4da-1448-4603-a34d-2efd9059811b | 2025-08-21 | Warnings, Adverse reactions | 208799 NDA208799 |
| Fluticasone Propionate and Salmeterol | FLUTICASONE PROPIONATE AND SALMETEROL | A-S Medication Solutions | 77269609-fb89-47c7-97cc-22e0183e91ae | 2025-04-02 | Warnings, Adverse reactions | 208799 NDA208799 50090-3271 50090-3272 50090-3387 |
| Fluticasone Propionate and Salmeterol | FLUTICASONE PROPIONATE AND SALMETEROL | Bryant Ranch Prepack | 84654ac7-e2b4-4fa1-b127-69aee03aecc0 | 2024-04-04 | Warnings, Adverse reactions | 208799 NDA208799 |
| Fluticasone Propionate and Salmeterol | FLUTICASONE PROPIONATE AND SALMETEROL | Teva Pharmaceuticals USA, Inc. | 43a27267-2f2b-410d-9c30-9cb95f35d9a1 | 2024-02-09 | Warnings, Adverse reactions | 208799 NDA208799 0093-3607 0093-3609 0093-3608 |
| AirDuo RespiClick | FLUTICASONE PROPIONATE AND SALMETEROL | Teva Respiratory, LLC | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 2024-02-06 | Warnings, Adverse reactions | 208799 NDA208799 59310-805 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 50090-3271 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3271 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3271 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED | Current |
| 50090-3272 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3272 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3272 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED | Current |
| 50090-3387 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3387 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3387 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3387 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3387 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3387 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol | A-S Medication Solutions | NDA AUTHORIZED | Current |
| 59310-111 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-111 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-111 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-111 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-111 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-129 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-129 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-129 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-129 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-129 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-136 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-136 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-136 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-136 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-136 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-510 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-510 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-510 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-510 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-510 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-520 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-520 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-520 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-520 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-520 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-530 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-530 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-530 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-530 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-530 | AirDuo Digihaler | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-805 | AirDuo RespiClick | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-805 | AirDuo RespiClick | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-805 | AirDuo RespiClick | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-805 | AirDuo RespiClick | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-805 | AirDuo RespiClick | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-805 | AirDuo RespiClick | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-805 | AirDuo RespiClick | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
| 59310-805 | AirDuo RespiClick | Fluticasone Propionate and Salmeterol | Teva Respiratory, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76630 | SUPPL | 2023-11-20 |
| 76624 | SUPPL | 2023-11-17 |
| 70550 | SUPPL | 2022-03-17 |
| 70452 | SUPPL | 2022-03-10 |
| 68059 | SUPPL | 2021-07-13 |
| 68049 | SUPPL | 2021-07-12 |
| 61980 | SUPPL | 2020-02-27 |
| 61957 | SUPPL | 2020-02-25 |
| 52915 | SUPPL | 2018-03-12 |
| 52822 | SUPPL | 2018-03-06 |
| 50880 | SUPPL | 2017-12-27 |
| 50843 | SUPPL | 2017-12-22 |
| 48045 | ORIG | 2017-04-14 |
| 47040 | ORIG | 2017-01-31 |
| 47035 | ORIG | 2017-01-27 |
| 51128 | ORIG | 1900-01-01 |
| 51127 | ORIG | 1900-01-01 |
| 51126 | ORIG | 1900-01-01 |