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Application 203836
- Type
- ANDA
- Sponsor
- PAR FORM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49884-335 | fluoxetine hydrochloride | fluoxetine hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-335 | fluoxetine hydrochloride | fluoxetine hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-335 | fluoxetine hydrochloride | fluoxetine hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-336 | fluoxetine hydrochloride | fluoxetine hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-336 | fluoxetine hydrochloride | fluoxetine hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-336 | fluoxetine hydrochloride | fluoxetine hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 63629-2197 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2197 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2197 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2198 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2198 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2198 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2199 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2199 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2199 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2199 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2200 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2200 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2200 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8989 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8990 | fluoxetine hydrochloride | fluoxetine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 70518-3083 | fluoxetine hydrochloride | fluoxetine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 45200 | ORIG | 2016-08-19 |