Application 213590
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51862-590 | Chlorpromazine | Chlorpromazine Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-592 | Chlorpromazine | Chlorpromazine Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-594 | Chlorpromazine | Chlorpromazine Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-596 | Chlorpromazine | Chlorpromazine Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-598 | Chlorpromazine | Chlorpromazine Hydrochloride | Mayne Pharma Inc. | ANDA | Current |