Application 076934
- Type
- ANDA
- Sponsor
- ACI HEALTHCARE LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | CONCENTRATE;ORAL | EQ 20MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10135-694 | Sertraline Hydrochloride | Sertraline Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 63629-8774 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-8774 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-8774 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-8774 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71093-143 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-143 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-143 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-143 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23843 | ORIG | 2006-07-05 |
| 31176 | ORIG | 2006-07-03 |