Application 021108
- Type
- NDA
- Sponsor
- VALEANT PHARMS NORTH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RENOVA | TRETINOIN | CREAM;TOPICAL | 0.02% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021108-001 | RENOVA | TRETINOIN | 0.02% | CREAM / TOPICAL | RLD, RS | 2000-08-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N021108-001 | RENOVA | 0.02% | CREAM / TOPICAL | RLD, RS | 2000-08-31 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021108-001 | RENOVA | 0.02% | CREAM / TOPICAL | RLD, RS | 2000-08-31 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021108-001 | RENOVA | 0.02% | CREAM / TOPICAL | RLD, RS | 2000-08-31 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021108-001 | RENOVA | 0.02% | CREAM / TOPICAL | RLD, RS | 2000-08-31 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021108-001 | 6531141 | 2020-03-07 | 74a2ff9319b5… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021108-001 | 6531141 | 2020-03-07 | 8869cabd3fbd… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021108-001 | 6531141 | 2020-03-07 | c0c555d07b60… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021108-001 | 6531141 | 2020-03-07 | 3f01610625f2… | |||
| 2019-09-15 20:21 UTC | 2019-09 | N021108-001 | 6531141 | 2020-03-07 | b00525d2431f… | |||
| 2019-07-19 19:46 UTC | 2019-07 | N021108-001 | 6531141 | 2020-03-07 | 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 |
|---|---|---|---|---|---|---|
| Renova | TRETINOIN | Bausch Health US LLC | 9f0a0e8d-1051-48a4-80c5-1bd260dd9c36 | 2026-02-24 | Warnings, Adverse reactions | 021108 NDA021108 0187-5150 |
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 |
|---|---|---|---|---|---|
| 0187-5150 | Renova | Tretinoin | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-5150 | Renova | Tretinoin | Bausch Health US LLC | NDA | Current |
| 0187-5150 | Renova | Tretinoin | Bausch Health Americas Inc. | NDA | Current |
| 0187-5150 | Renova | Tretinoin | Bausch Health US LLC | NDA | Current |
| 0187-5150 | Renova | Tretinoin | Bausch Health US LLC | NDA | Current |
| 42254-165 | Renova | Tretinoin | Rebel Distributors Corp | NDA | Current |