Application 075245
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 20MG BASE | No | No |
| 002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG 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 |
|---|
| 0615-1357 | fluoxetine | fluoxetine hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 67046-211 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44251 | ORIG | 2005-08-01 |
| 30814 | ORIG | 2004-06-04 |