Application 076006
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
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 |
|---|
| 16714-112 | Fluoxetine | Fluoxetine | NorthStar Rx LLC | ANDA | Current |
| 16714-112 | Fluoxetine | Fluoxetine | NorthStar Rx LLC | ANDA | Current |
| 16714-113 | Fluoxetine | Fluoxetine | NorthStar Rx LLC | ANDA | Current |
| 16714-113 | Fluoxetine | Fluoxetine | NorthStar Rx LLC | ANDA | Current |
| 43598-566 | Fluoxetine | Fluoxetine | Dr.Reddy's Laboratories Inc. | ANDA | Current |
| 43598-566 | Fluoxetine | Fluoxetine | Dr.Reddy's Laboratories Inc. | ANDA | Current |
| 45865-378 | Fluoxetine | Fluoxetine | medsource pharmaceuticals | ANDA | Current |
| 55111-150 | Fluoxetine | Fluoxetine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-150 | Fluoxetine | Fluoxetine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55700-589 | Fluoxetine | Fluoxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 70518-1775 | Fluoxetine | Fluoxetine | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23791 | ORIG | 2005-08-01 |