Application 020743
- Type
- NDA
- Sponsor
- VALEANT PHARMS NORTH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORITATE | METRONIDAZOLE | CREAM;TOPICAL | 1% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020743-001 | NORITATE | METRONIDAZOLE | 1% | CREAM / TOPICAL | RLD, RS | 1997-09-26 |
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 | N020743-001 | NORITATE | 1% | CREAM / TOPICAL | RLD, RS | 1997-09-26 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020743-001 | NORITATE | 1% | CREAM / TOPICAL | RLD, RS | 1997-09-26 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020743-001 | NORITATE | 1% | CREAM / TOPICAL | RLD, RS | 1997-09-26 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020743-001 | NORITATE | 1% | CREAM / TOPICAL | RLD, RS | 1997-09-26 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Metronidazole | METRONIDAZOLE | Oceanside Pharmaceuticals | cdf2e251-4bbc-4434-9b00-bef6284491e4 | 2022-06-21 | Adverse reactions | 020743 NDA020743 |
| Noritate | METRONIDAZOLE | Bausch Health US, LLC | 706b09da-6cf9-421d-8e91-f3999474d322 | 2020-06-01 | Adverse reactions | 020743 NDA020743 0187-5202 |
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 |
|---|---|---|---|---|---|
| 0187-5202 | Noritate | metronidazole | Bausch Health US, LLC | NDA | Current |
| 0187-5202 | Noritate | metronidazole | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-5202 | Noritate | metronidazole | Bausch Health US, LLC | NDA | Current |
| 0187-5202 | Noritate | metronidazole | Bausch Health US, LLC | NDA | Current |
| 0187-5202 | Noritate | metronidazole | Bausch Health US, Inc. | NDA | Current |