Details for New Drug Application (NDA): 214719
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NDA 214719 describes ERLOTINIB HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Chartwell Rx, Eugia Pharma, Hetero Labs Ltd V, MSN, Natco Pharma Ltd, Rising, Shilpa, Sun Pharm, Teva Pharms Usa Inc, and Zydus Pharms, and is included in thirteen NDAs. It is available from ten suppliers. Additional details are available on the ERLOTINIB HYDROCHLORIDE profile page.
The generic ingredient in ERLOTINIB HYDROCHLORIDE is erlotinib hydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
The generic ingredient in ERLOTINIB HYDROCHLORIDE is erlotinib hydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
Summary for 214719
| Tradename: | ERLOTINIB HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | erlotinib hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 214719
| Mechanism of Action | Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 214719
Suppliers and Packaging for NDA: 214719
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 214719 | ANDA | Alembic Pharmaceuticals Limited | 46708-565 | 46708-565-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-565-30) |
| ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 214719 | ANDA | Alembic Pharmaceuticals Limited | 46708-565 | 46708-565-90 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-565-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Jul 8, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jul 8, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jul 8, 2021 | TE: | AB | RLD: | No | ||||
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