Application 202343
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202343-001 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | |
| N202343-002 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | |
| N202343-003 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | |
| N202343-004 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | |
| N202343-005 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | |
| N202343-006 | JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202343-001 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 2011-11-04 |
| N202343-001 | 7326708*PED | 2026-10-11 | Pediatric extension | ||
| N202343-002 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | |
| N202343-002 | 7326708*PED | 2026-10-11 | Pediatric extension | ||
| N202343-003 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | |
| N202343-003 | 7326708*PED | 2026-10-11 | Pediatric extension | ||
| N202343-004 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | |
| N202343-004 | 7326708*PED | 2026-10-11 | Pediatric extension | ||
| N202343-005 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | |
| N202343-005 | 7326708*PED | 2026-10-11 | Pediatric extension | ||
| N202343-006 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | |
| N202343-006 | 7326708*PED | 2026-10-11 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N202343-001 | JUVISYNC | 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202343-002 | JUVISYNC | 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202343-003 | JUVISYNC | 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202343-004 | JUVISYNC | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202343-005 | JUVISYNC | 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202343-006 | JUVISYNC | 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-001 | JUVISYNC | 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-002 | JUVISYNC | 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-003 | JUVISYNC | 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-004 | JUVISYNC | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-005 | JUVISYNC | 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-006 | JUVISYNC | 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-001 | JUVISYNC | 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-002 | JUVISYNC | 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-003 | JUVISYNC | 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-004 | JUVISYNC | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-005 | JUVISYNC | 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-006 | JUVISYNC | 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202343-001 | JUVISYNC | 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202343-002 | JUVISYNC | 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202343-003 | JUVISYNC | 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202343-004 | JUVISYNC | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202343-005 | JUVISYNC | 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202343-006 | JUVISYNC | 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202343-001 | JUVISYNC | 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202343-002 | JUVISYNC | 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202343-003 | JUVISYNC | 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202343-004 | JUVISYNC | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202343-005 | JUVISYNC | 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202343-006 | JUVISYNC | 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202343-001 | JUVISYNC | 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202343-002 | JUVISYNC | 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202343-003 | JUVISYNC | 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202343-004 | JUVISYNC | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202343-005 | JUVISYNC | 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202343-006 | JUVISYNC | 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202343-001 | JUVISYNC | 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202343-002 | JUVISYNC | 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202343-003 | JUVISYNC | 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202343-004 | JUVISYNC | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2012-09-18 | 03ed91905a0d… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N202343-001 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 2011-11-04 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202343-001 | 7326708*PED | 2026-10-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202343-002 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202343-002 | 7326708*PED | 2026-10-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202343-003 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202343-003 | 7326708*PED | 2026-10-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202343-004 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202343-004 | 7326708*PED | 2026-10-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202343-005 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202343-005 | 7326708*PED | 2026-10-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202343-006 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202343-006 | 7326708*PED | 2026-10-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202343-001 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 2011-11-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-001 | 7326708*PED | 2026-10-11 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202343-002 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-002 | 7326708*PED | 2026-10-11 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202343-003 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-003 | 7326708*PED | 2026-10-11 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202343-004 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-004 | 7326708*PED | 2026-10-11 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202343-005 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-005 | 7326708*PED | 2026-10-11 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202343-006 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202343-006 | 7326708*PED | 2026-10-11 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-001 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 2011-11-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-001 | 7326708*PED | 2026-10-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-002 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-002 | 7326708*PED | 2026-10-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-003 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-003 | 7326708*PED | 2026-10-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-004 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-004 | 7326708*PED | 2026-10-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-005 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-005 | 7326708*PED | 2026-10-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-006 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202343-006 | 7326708*PED | 2026-10-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202343-001 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 2011-11-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202343-001 | 7326708*PED | 2026-10-11 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202343-002 | 7326708 | 2026-04-11 | U-1188 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202343-002 | 7326708*PED | 2026-10-11 | Pediatric extension | 6a471c1ec25d… |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32243 | SUPPL | 2014-02-26 |
| 19330 | SUPPL | 2014-02-25 |
| 19328 | SUPPL | 2013-10-31 |
| 32241 | SUPPL | 2013-10-28 |
| 32242 | SUPPL | 2013-08-22 |
| 19329 | SUPPL | 2013-08-19 |
| 10033 | SUPPL | 2013-02-13 |
| 40172 | SUPPL | 2013-02-11 |
| 40171 | SUPPL | 2012-11-06 |
| 32240 | SUPPL | 2012-11-06 |
| 32239 | SUPPL | 2012-11-06 |
| 19327 | SUPPL | 2012-11-06 |
| 32238 | SUPPL | 2012-09-24 |
| 10032 | SUPPL | 2012-09-24 |
| 10031 | SUPPL | 2012-09-24 |
| 40170 | SUPPL | 2012-09-20 |
| 19326 | SUPPL | 2012-09-20 |
| 19325 | SUPPL | 2012-09-20 |
| 44853 | ORIG | 2012-07-13 |
| 43397 | ORIG | 2012-07-13 |
| 40169 | ORIG | 2011-10-07 |
| 23492 | ORIG | 2011-10-07 |
| 10030 | ORIG | 2011-10-07 |