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Application 213614
- Type
- ANDA
- Sponsor
- MANKIND PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 0.5MG BASE | No | No |
| 002 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63629-2517 | Alosetron | Alosetron | Bryant Ranch Prepack | ANDA | Current |
| 63629-2517 | Alosetron | Alosetron | Bryant Ranch Prepack | ANDA | Current |
| 63629-2518 | Alosetron | Alosetron | Bryant Ranch Prepack | ANDA | Current |
| 63629-2518 | Alosetron | Alosetron | Bryant Ranch Prepack | ANDA | Current |
| 70756-701 | Alosetron | Alosetron | Lifestar Pharma LLC | ANDA | Current |
| 70756-701 | Alosetron | Alosetron | Lifestar Pharma LLC | ANDA | Current |
| 70756-702 | Alosetron | Alosetron | Lifestar Pharma LLC | ANDA | Current |
| 70756-702 | Alosetron | Alosetron | Lifestar Pharma LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75382 | SUPPL | 2023-09-08 |