Skip to contentApplication 209419
- Type
- ANDA
- Sponsor
- PAR PHARM INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 60MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49884-468 | Fluoxetine | Fluoxetine | Par Pharmaceutical, Inc. | ANDA | Current |
| 63629-2201 | Fluoxetine | Fluoxetine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2201 | Fluoxetine | Fluoxetine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2201 | Fluoxetine | Fluoxetine | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50741 | ORIG | 2017-12-18 |