Application 016921
- Type
- NDA
- Sponsor
- VALEANT INTL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RETIN-A | TRETINOIN | SOLUTION;TOPICAL | 0.05% | Yes | No |
| 002 | RETIN-A | TRETINOIN | SWAB;TOPICAL | 0.05% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016921-001 | RETIN-A | TRETINOIN | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | ||
| N016921-002 | RETIN-A | TRETINOIN | 0.05% | SWAB / TOPICAL | Approved before 1982 |
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 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Tretinoin Cream | TRETINOIN | Obagi Cosmeceuticals LLC | 745cc3ce-60b4-4479-a055-316817567949 | 2025-02-11 | Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Actavis Pharma, Inc. | b5e385a2-f6f9-41cb-8a33-eedba397043f | 2024-12-11 | Adverse reactions | TRETINOIN |
| Tretinoin (Microsphere) | TRETINOIN | Mayne Pharma | ed2103ee-c9d5-4b3d-b525-318cf67be050 | 2024-10-28 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Mylan Pharmaceuticals Inc. | ba377a5e-e48a-4bd9-9d76-929d70793396 | 2024-10-09 | Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Bryant Ranch Prepack | 7a7974c7-8b6c-41ae-9a48-a08a1439087a | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | A-S Medication Solutions | 06ebaf8e-3648-493e-9b6a-9adef67bc65f | 2024-05-22 | Warnings, Adverse reactions | TRETINOIN |
| Retin-A | TRETINOIN | Bausch Health US, LLC | 9556d73d-c573-4e0a-9feb-764ce2d1107b | 2024-05-17 | Adverse reactions | Retin-A TRETINOIN |
| Tretinoin | TRETINOIN | Alembic Pharmaceuticals Inc. | d6cc176c-ca71-481b-93c4-36565770a7b5 | 2024-05-01 | Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Zydus Lifesciences Limited | 047989fc-6e33-4f19-8ba7-5fb63bb06cf3 | 2024-04-26 | TRETINOIN | |
| Tretinoin | TRETINOIN | Viona Pharmaceuticals Inc | 2ee7844c-e5ee-4d15-80c7-c07a9f23ccdd | 2024-04-26 | Warnings, Adverse reactions | TRETINOIN |
| TRETINOIN | TRETINOIN | Bryant Ranch Prepack | 5e84c976-d4d6-4d8f-a448-8afb47e2fbff | 2024-04-03 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Oceanside Pharmaceuticals | febda58b-c9ee-4b95-bee7-dca5f2645f98 | 2024-02-01 | Warnings, Adverse reactions | TRETINOIN |
| Atralin | TRETINOIN | Bausch Health US, LLC | b6b45969-a64a-4ce3-b3b6-157d2568a301 | 2024-02-01 | Warnings, Adverse reactions | TRETINOIN |
| TRETINOIN | TRETINOIN | A-S Medication Solutions | 0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5 | 2024-01-28 | Warnings, Adverse reactions | TRETINOIN |
| TRETINOIN | TRETINOIN | Padagis US LLC | 4889c7f8-37d0-4f1a-9829-bca107806586 | 2023-12-31 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | A-S Medication Solutions | c7860dcd-91b0-44e0-98d6-a843b16457e1 | 2023-10-25 | Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Mylan Pharmaceuticals Inc. | ce5f4f14-5e60-4cc1-bcb3-1fa9b8aa9cd5 | 2022-07-25 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Obagi Cosmeceuticals LLC | c5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b | 2021-05-01 | Warnings, Adverse reactions | TRETINOIN |
| Altreno | TRETINOIN | Bausch Health US, LLC | 1412aba5-71aa-4cce-8db4-c189bed1852c | 2020-03-02 | Warnings, Adverse reactions | TRETINOIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.