Application 213286
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA 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 |
|---|
| 59651-308 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |
| 59651-308 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |
| 59651-308 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |
| 59651-309 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |
| 59651-309 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |
| 59651-309 | Fluoxetine | Fluoxetine | Aurobindo Pharma Limited | ANDA | Current |