Application 077977
- Type
- ANDA
- Sponsor
- SUN PHARM INDS 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 |
| 004 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | No | No |
| 005 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 200MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63304-164 | Sertraline Hydrochloride | Sertraline Hydrochloride | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-165 | Sertraline Hydrochloride | Sertraline Hydrochloride | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-166 | Sertraline Hydrochloride | Sertraline Hydrochloride | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-167 | Sertraline Hydrochloride | Sertraline Hydrochloride | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-168 | Sertraline Hydrochloride | Sertraline Hydrochloride | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |