Skip to contentApplication 206113
- Type
- ANDA
- Sponsor
- PAR PHARM INC
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 |
|---|
| 49884-819 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-819 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-819 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-820 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-820 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-820 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75380 | SUPPL | 2023-09-08 |