Application 077162
- Type
- ANDA
- Sponsor
- CHARTWELL MOLECULAR
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 | 150MG | No | No |
| 005 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET; ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69097-155 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cipla USA Inc. | ANDA | Current |
| 69097-156 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cipla USA Inc. | ANDA | Current |
| 69097-157 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cipla USA Inc. | ANDA | Current |