Application 091365
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL | No | No |
| 002 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-909 | GEMCITABINE | GEMCITABINE HYDROCHLORIDE | NorthStar Rx LLC | ANDA | Current |
| 16714-909 | GEMCITABINE | GEMCITABINE HYDROCHLORIDE | NorthStar Rx LLC | ANDA | Current |
| 16714-930 | GEMCITABINE | GEMCITABINE HYDROCHLORIDE | NorthStar Rx LLC | ANDA | Current |
| 16714-930 | GEMCITABINE | GEMCITABINE HYDROCHLORIDE | NorthStar Rx LLC | ANDA | Current |
| 55111-686 | gemcitabine | Gemcitabine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-686 | gemcitabine | gemcitabine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-687 | gemcitabine | Gemcitabine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-687 | gemcitabine | gemcitabine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55390-391 | gemcitabine | gemcitabine | Bedford Laboratories | ANDA | Current |
| 71288-113 | GEMCITABINE | GEMCITABINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-113 | GEMCITABINE | GEMCITABINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-114 | GEMCITABINE | GEMCITABINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-114 | GEMCITABINE | GEMCITABINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | ANDA | Current |