Application 078045
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-5410 | Fluoxetine Hydrochloride | fluoxetine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5410 | Fluoxetine Hydrochloride | fluoxetine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5420 | Fluoxetine Hydrochloride | fluoxetine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5420 | Fluoxetine Hydrochloride | fluoxetine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44372 | ORIG | 2008-11-25 |