Application 216953
- Type
- ANDA
- Sponsor
- APTAPHARMA INC
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 |
|---|---|---|---|---|---|
| 0832-6032 | Fluoxetine hydrochloride | Fluoxetine hydrochloride | Upsher-Smith Laboratories, LLC | ANDA | Current |