Application 211960
- Type
- ANDA
- Sponsor
- SHILPA MEDICARE LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ERLOTINIB HYDROCHLORIDE | ERLOTINIB HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | ERLOTINIB HYDROCHLORIDE | ERLOTINIB HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No |
| 003 | ERLOTINIB HYDROCHLORIDE | ERLOTINIB HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59923-725 | Erlotinib | Erlotinib | Areva Pharmaceuticals | ANDA | Current |
| 59923-725 | Erlotinib | Erlotinib | Areva Pharmaceuticals | ANDA | Current |
| 59923-726 | Erlotinib | Erlotinib | Areva Pharmaceuticals | ANDA | Current |
| 59923-726 | Erlotinib | Erlotinib | Areva Pharmaceuticals | ANDA | Current |
| 59923-727 | Erlotinib | Erlotinib | Areva Pharmaceuticals | ANDA | Current |
| 59923-727 | Erlotinib | Erlotinib | Areva Pharmaceuticals | ANDA | Current |
| 72485-217 | Erlotinib | Erlotinib hydrochloride | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-218 | Erlotinib | Erlotinib hydrochloride | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-219 | Erlotinib | Erlotinib hydrochloride | Armas Pharmaceuticals Inc. | ANDA | Current |