Application 210928
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZELAIC ACID | AZELAIC ACID | AEROSOL, FOAM;TOPICAL | 15% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210928-001 | AZELAIC ACID | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 |
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 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | AB | 2020-10-07 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210928-001 | AZELAIC ACID | 15% | AEROSOL, FOAM / TOPICAL | 2020-10-07 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | A210928-001 | AB | 1 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| 10% Azelaic Acid | AZELAIC ACID CREAM | Guangzhou Ariel Medical Technology Co., Ltd. | 55b03daa-b6d4-9edf-e063-6394a90ac4d1 | 2026-07-03 | Warnings | AZELAIC ACID |
| Azelaic Acid Gel | AZELAIC ACID | Bryant Ranch Prepack | 9c151fc7-cb0b-4931-9c1b-0c29f46ac21f | 2026-05-21 | Warnings, Adverse reactions | AZELAIC ACID |
| 14% Azelaic Acid Acne | AZELAIC ACID | Guangdong Bisutang Biotechnology Co., Ltd. | 4ccaa734-83be-611b-e063-6294a90ab3bf | 2026-03-11 | Warnings | AZELAIC ACID |
| Azelaic Acid Gel | AZELAIC ACID | Encube Ethicals, Inc. | ab3f174c-a3c4-4ae9-b0bc-954efaadf8de | 2025-12-24 | Warnings, Adverse reactions | AZELAIC ACID |
| Azelaic Acid | AZELAIC ACID | Sun Pharmaceutical Industries, Inc. | d4e9e95d-1ebd-44df-a91e-59819715659c | 2025-08-22 | Warnings, Adverse reactions | Azelaic Acid AZELAIC ACID |
| AZELEX | AZELAIC ACID | Almirall, LLC | ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75 | 2024-03-04 | Warnings, Adverse reactions | AZELAIC ACID |
| azelaic acid | AZELAIC ACID | Actavis Pharma, Inc. | 66298d50-d4e2-4852-bbab-581389c488cb | 2022-05-30 | Warnings, Adverse reactions | azelaic acid AZELAIC ACID |
| azelaic acid | AZELAIC ACID | Glenmark Pharmaceuticals Inc., USA | 0b5ab22e-c78a-4429-9a76-a4ba2d11fcde | 2021-12-23 | Warnings, Adverse reactions | azelaic acid AZELAIC ACID |
| Azelaic Acid Gel | AZELAIC ACID | Sandoz Inc. | 66178511-5c1a-4ecd-bc98-2ceb54e710ac | 2021-11-11 | Warnings, Adverse reactions | AZELAIC ACID |
| FINACEA FOAM | AZELAIC ACID | LEO Pharma Inc. | 9fabd24e-4c3b-49a0-aa5f-c8d75ae67572 | 2020-12-08 | Warnings, Adverse reactions | AZELAIC ACID |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55240 | ORIG | 2018-08-20 |