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Application 216342
- Type
- ANDA
- Sponsor
- EUGIA PHARMA
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 |
|---|
| 59651-530 | Erlotinib | Erlotinib | Aurobindo Pharma Limited | ANDA | Current |
| 59651-531 | Erlotinib | Erlotinib | Aurobindo Pharma Limited | ANDA | Current |
| 59651-532 | Erlotinib | Erlotinib | Aurobindo Pharma Limited | ANDA | Current |