Application 208488
- Type
- ANDA
- Sponsor
- NATCO PHARMA LTD
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51991-890 | Erlotinib | Erlotinib Hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-890 | Erlotinib | Erlotinib Hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-891 | Erlotinib | Erlotinib Hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-891 | Erlotinib | Erlotinib Hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-892 | Erlotinib | Erlotinib Hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-892 | Erlotinib | Erlotinib Hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |