Application 076881
- 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 | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71093-129 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-129 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-129 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-130 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-130 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-130 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-131 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-131 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-131 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | ACI Healthcare USA, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44324 | ORIG | 2005-08-01 |