Application 019508
- Type
- NDA
- Sponsor
- SMITHKLINE BEECHAM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AXID | NIZATIDINE | CAPSULE;ORAL | 150MG | No | No |
| 002 | AXID | NIZATIDINE | CAPSULE;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019508-001 | AXID | NIZATIDINE | 150MG | CAPSULE / ORAL | 1988-04-12 | ||
| N019508-002 | AXID | NIZATIDINE | 300MG | CAPSULE / ORAL | 1988-04-12 |
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 | N019508-001 | AXID | 150MG | CAPSULE / ORAL | 1988-04-12 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019508-002 | AXID | 300MG | CAPSULE / ORAL | 1988-04-12 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019508-001 | AXID | 150MG | CAPSULE / ORAL | 1988-04-12 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019508-002 | AXID | 300MG | CAPSULE / ORAL | 1988-04-12 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019508-001 | AXID | 150MG | CAPSULE / ORAL | 1988-04-12 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019508-002 | AXID | 300MG | CAPSULE / ORAL | 1988-04-12 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019508-001 | AXID | 150MG | CAPSULE / ORAL | 1988-04-12 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019508-002 | AXID | 300MG | CAPSULE / ORAL | 1988-04-12 | 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 |
|---|---|---|---|---|---|---|
| Nizatidine | NIZATIDINE | Epic Pharma, LLC | e9957997-8b85-48a0-9bb3-b878cb223236 | 2025-01-02 | Adverse reactions | NIZATIDINE |
| NIZATIDINE | NIZATIDINE | Amneal Pharmaceuticals LLC | 39e62997-8781-449a-e054-00144ff88e88 | 2024-10-23 | Adverse reactions | NIZATIDINE |
| Nizatidine | NIZATIDINE | Actavis Pharma, Inc. | 367a1004-59c1-4474-a4f6-ce8bf5a1b043 | 2022-06-30 | Adverse reactions | NIZATIDINE |
| Nizatidine | NIZATIDINE | Dr Reddy's Laboratories Limited | faaa7cc4-fda9-d5b8-de2a-71c8744ccb76 | 2018-12-06 | Adverse reactions | NIZATIDINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.