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Application 216448
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70954-600 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Novitium Pharma LLC | ANDA | Current |