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Application 216232
- Type
- ANDA
- Sponsor
- MICRO LABS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
| 002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 20MG BASE | No | No |
| 003 | 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 |
|---|
| 42571-387 | FLUOXETINE | FLUOXETINE | Micro Labs Limited | ANDA | Current |
| 42571-388 | FLUOXETINE | FLUOXETINE | Micro Labs Limited | ANDA | Current |
| 42571-389 | FLUOXETINE | FLUOXETINE | Micro Labs Limited | ANDA | Current |