Application 018869
- Type
- NDA
- Sponsor
- BAYER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NIMOTOP | NIMODIPINE | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018869-001 | NIMOTOP | NIMODIPINE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-28 |
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UTC | 2022-10 | N018869-001 | NIMOTOP | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-28 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N018869-001 | NIMOTOP | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-28 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018869-001 | NIMOTOP | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-28 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018869-001 | NIMOTOP | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-28 | a50c72e98297… |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 |
|---|---|---|---|---|---|---|
| Nimodipine | NIMODIPINE | BIONPHARMA INC. | e65d5108-22a2-4d87-a78d-15606f3cc9e2 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | NIMODIPINE |
| Nymalize | NIMODIPINE | Azurity Pharmaceuticals, Inc. | e660fa26-b5c4-4d6d-8887-9e22b6666a10 | 2024-08-30 | Warnings, Adverse reactions | NIMODIPINE |
| nimodipine | NIMODIPINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | a323ebd8-ef1b-439b-93d1-ba73a5b0127d | 2024-08-16 | Boxed warning, Warnings, Adverse reactions | NIMODIPINE |
| Nimodipine | NIMODIPINE | Camber Pharmaceuticals, Inc. | f829de8b-fabd-4aec-ac8d-c9aaef7be55b | 2024-07-20 | Warnings, Adverse reactions | NIMODIPINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.