Application 212144
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 004 | CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 005 | CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68462-861 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-861 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-862 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-862 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-863 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-863 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-864 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-864 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-865 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-865 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 70518-3280 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3435 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67039 | ORIG | 2021-04-13 |