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Application 210363
- Type
- ANDA
- Sponsor
- BELOTECA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DIAZEPAM | DIAZEPAM | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69339-136 | Diazepam | DIAZEPAM | Dash Pharmaceuticals LLC | ANDA | Current |
| 69339-136 | Diazepam | DIAZEPAM | Dash Pharmaceuticals LLC | ANDA | Current |
| 69339-136 | Diazepam | DIAZEPAM | Dash Pharmaceuticals LLC | ANDA | Current |
| 69339-136 | Diazepam | DIAZEPAM | Dash Pharmaceuticals LLC | ANDA | Current |
| 70518-2358 | Diazepam | DIAZEPAM | REMEDYREPACK INC. | ANDA | Current |
| 70518-2358 | Diazepam | DIAZEPAM | REMEDYREPACK INC. | ANDA | Current |
| 70518-2358 | Diazepam | DIAZEPAM | REMEDYREPACK INC. | ANDA | Current |
| 70518-2358 | Diazepam | DIAZEPAM | REMEDYREPACK INC. | ANDA | Current |
| 70518-2358 | Diazepam | DIAZEPAM | REMEDYREPACK INC. | ANDA | Current |
| 72572-140 | Diazepam | DIAZEPAM | Civica, Inc. | ANDA | Current |
| 72572-140 | Diazepam | DIAZEPAM | Civica, Inc. | ANDA | Current |
| 72572-140 | Diazepam | DIAZEPAM | Civica, Inc. | ANDA | Current |
| 72572-140 | Diazepam | DIAZEPAM | Civica, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73487 | SUPPL | 2023-02-13 |