Application 079209
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | SOLUTION;ORAL | EQ 20MG BASE/5ML | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-7195 | Fluoxetine | Fluoxetine | Major Pharmaceuticals | ANDA | Current |
| 65862-306 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-306 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-306 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-306 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-306 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-306 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |