Application 205636
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROAIR RESPICLICK | ALBUTEROL SULFATE | POWDER, METERED;INHALATION | EQ 0.09MG BASE/INH | Yes | Yes |
| 002 | PROAIR DIGIHALER | ALBUTEROL SULFATE | POWDER, METERED;INHALATION | EQ 0.09MG BASE/INH | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205636-001 | PROAIR RESPICLICK | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | |
| N205636-002 | PROAIR DIGIHALER | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205636-001 | PROAIR RESPICLICK | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD, RS | 2015-03-31 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205636-002 | PROAIR DIGIHALER | EQ 0.09MG BASE/INH | POWDER, METERED / INHALATION | RLD | 2018-12-21 | 74a2ff9319b5… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | N205636-001 | 10765820 | 2025-05-19 | Drug product | 2020-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-001 | 9463288 | 2025-05-19 | Drug product | 2016-11-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-001 | 8651103 | 2028-03-26 | Drug product | 2015-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-001 | 10022510 | 2031-05-18 | Drug product | 2018-08-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-001 | 10124131 | 2031-05-18 | Drug product | 2018-12-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-001 | 9731087 | 2031-05-18 | Drug product | 2017-08-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-001 | 9216260 | 2031-06-28 | Drug product | 2016-01-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-001 | 8978966 | 2032-01-13 | Drug product | 2016-01-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 10765820 | 2025-05-19 | Drug product | 2020-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 9463288 | 2025-05-19 | Drug product | 2019-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 8651103 | 2028-03-26 | Drug product | 2019-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 10022510 | 2031-05-18 | Drug product | 2019-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 10124131 | 2031-05-18 | Drug product | 2019-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 9731087 | 2031-05-18 | Drug product | 2019-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 9216260 | 2031-06-28 | Drug product | 2019-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 8978966 | 2032-01-13 | Drug product | 2019-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 9782550 | 2035-08-28 | Drug product | 2019-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 9782551 | 2035-08-28 | Drug product | 2019-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 10918816 | 2035-12-14 | Drug product | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 10569034 | 2036-08-16 | Drug product | 2020-03-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 11351317 | 2038-02-10 | Drug product | 2022-06-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 11357935 | 2038-09-24 | Drug product | 2022-07-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 11000653 | 2038-12-18 | Drug product | 2021-06-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 11344685 | 2039-09-26 | Drug product | 2022-06-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 11439777 | 2040-05-24 | Drug product | 2022-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 11464923 | 2040-06-19 | Drug product | 2022-11-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 11173259 | 2040-07-06 | Drug product | 2021-12-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205636-002 | 11266796 | 2041-02-22 | Drug product | 2022-04-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-001 | 10765820 | 2025-05-19 | Drug product | 2020-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-001 | 9463288 | 2025-05-19 | Drug product | 2016-11-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-001 | 8651103 | 2028-03-26 | Drug product | 2015-04-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-001 | 10022510 | 2031-05-18 | Drug product | 2018-08-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-001 | 10124131 | 2031-05-18 | Drug product | 2018-12-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-001 | 9731087 | 2031-05-18 | Drug product | 2017-08-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-001 | 9216260 | 2031-06-28 | Drug product | 2016-01-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-001 | 10561808 | 2032-01-01 | Drug product | 2020-03-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-001 | 8978966 | 2032-01-13 | Drug product | 2016-01-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-002 | 10765820 | 2025-05-19 | Drug product | 2020-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-002 | 9463288 | 2025-05-19 | Drug product | 2019-01-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205636-002 | 8651103 | 2028-03-26 | Drug product | 2019-01-09 | fd3edfee7708… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N205636-001 | NPP | 2019-04-28 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N205636-001 | NPP | 2019-04-28 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N205636-001 | NPP | 2019-04-28 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N205636-001 | NPP | 2019-04-28 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Albuterol Sulfate | ALBUTEROL SULFATE | Preferred Pharmaceuticals, Inc. | 081b7bbb-6692-4512-b135-863b73bf30a5 | 2025-10-13 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulate HFA | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 825975b1-a4a9-78ca-e053-2a91aa0a3948 | 2025-09-02 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | QUAGEN PHARMACEUTICALS LLC | 99a490cc-e41d-436b-9cf3-8facb7ac714f | 2025-07-03 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol sulfate | ALBUTEROL SULFATE | Preferred Pharmaceuticals, Inc. | 99782bc8-56d9-41f8-935e-0d0de27f0c34 | 2025-05-19 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Preferred Pharmaceuticals Inc. | 1c72fd84-7dbc-45d0-ab88-fb4221ce369f | 2025-05-16 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol sulfate | ALBUTEROL SULFATE | Asclemed USA, Inc. | 264e2145-c7d4-4f4f-aa5b-9fe48a7c5b47 | 2025-05-07 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Proficient Rx LP | a6545fbe-b0a6-41ae-8bb6-91af38410f56 | 2025-04-01 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | Chartwell RX, LLC | 560df50c-e2c4-459f-9d89-bf7e6588949e | 2025-03-28 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Nephron Pharmaceuticals Corporation | ecc00500-58b8-491f-80df-dc6c89a08cae | 2025-03-21 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 813d49be-3651-6759-e053-2991aa0a6a9f | 2025-02-06 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol sulfate | ALBUTEROL SULFATE | Lupin Pharmaceuticals, Inc. | 973b8686-c6ce-4280-85c4-c1e7ceab3c09 | 2025-01-23 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol sulfate | ALBUTEROL SULFATE | A-S Medication Solutions | 52e209ac-7156-4496-ba5a-42ee59d45deb | 2025-01-22 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 749992b4-69e0-0cc8-e053-2991aa0aeb25 | 2025-01-08 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | HF Acquisition Co LLC, DBA HealthFirst | 9d4ef83f-8ca0-811e-e053-2995a90a6d0d | 2025-01-08 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | Preferred Pharmaceuticals, Inc. | 4aafc2dd-744d-4726-828f-70355aee6f70 | 2025-01-03 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Proficient Rx LP | 53eecdef-a7ff-4ca3-a313-d4b9c29c898d | 2025-01-01 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate HFA | ALBUTEROL SULFATE | Advanced Rx of Tennessee, LLC | 04c8a345-0a0d-5a01-e063-6294a90a40d2 | 2024-12-31 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Advanced Rx Pharmacy of Tennessee, LLC | f44b325d-0f74-552c-e053-2995a90ac1c9 | 2024-12-31 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate Inhalation | ALBUTEROL SULFATE | Amneal Pharmaceuticals NY LLC | 2e449282-ee58-4e36-b983-85c4e6f0864d | 2024-12-20 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Ingenus Pharmaceuticals, LLC | e14f5fd6-d01a-489d-9baa-61778b1352a8 | 2024-10-22 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 53002-1750 | ProAir RespiClick | Albuterol Sulfate | RPK Pharmaceuticals, Inc. | NDA | Current |
| 53002-1750 | ProAir RespiClick | Albuterol Sulfate | RPK Pharmaceuticals, Inc. | NDA | Current |
| 59310-117 | ProAir Digihaler | albuterol sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-117 | ProAir Digihaler | albuterol sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-117 | ProAir Digihaler | albuterol sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-117 | ProAir Digihaler | albuterol sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-117 | ProAir Digihaler | albuterol sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-117 | ProAir Digihaler | albuterol sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-117 | ProAir Digihaler | albuterol sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-540 | ProAir Digihaler | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-540 | ProAir Digihaler | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-540 | ProAir Digihaler | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-540 | ProAir Digihaler | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-540 | ProAir Digihaler | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-540 | ProAir Digihaler | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-580 | ProAir RespiClick | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-580 | ProAir RespiClick | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-580 | ProAir RespiClick | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-580 | ProAir RespiClick | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
| 59310-580 | ProAir RespiClick | Albuterol Sulfate | Teva Respiratory, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64774 | SUPPL | 2020-10-01 |
| 64763 | SUPPL | 2020-09-30 |
| 57161 | SUPPL | 2019-01-09 |
| 57160 | SUPPL | 2019-01-09 |
| 45292 | SUPPL | 2016-09-12 |
| 45264 | SUPPL | 2016-09-09 |
| 10481 | SUPPL | 2016-05-02 |
| 19669 | SUPPL | 2016-04-29 |
| 44928 | ORIG | 2016-03-02 |
| 22997 | ORIG | 2016-03-02 |
| 40487 | ORIG | 2015-04-28 |
| 32695 | ORIG | 2015-04-03 |
| 32696 | ORIG | 2015-03-10 |
| 51482 | SUPPL | 1900-01-01 |
| 51481 | SUPPL | 1900-01-01 |
| 51468 | SUPPL | 1900-01-01 |
| 51461 | ORIG | 1900-01-01 |
| 51459 | ORIG | 1900-01-01 |
| 51457 | ORIG | 1900-01-01 |