Application 076990
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 40MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 21695-054 | Fluoxetine | fluoxetine | Rebel Distributors Corp | ANDA | Current |
| 33261-883 | Fluoxetine | fluoxetine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-729 | Fluoxetine | fluoxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50436-0923 | Fluoxetine | fluoxetine | Unit Dose Services | ANDA | Current |
| 61919-490 | FLUOXETINE | FLUOXETINE | DirectRX | ANDA | Current |
| 61919-490 | FLUOXETINE | FLUOXETINE | DirectRX | ANDA | Current |
| 63187-089 | Fluoxetine | fluoxetine | Proficient Rx LP | ANDA | Current |
| 63187-089 | Fluoxetine | fluoxetine | Proficient Rx LP | ANDA | Current |
| 63304-632 | Fluoxetine | fluoxetine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23845 | ORIG | 2005-08-01 |