Details for New Drug Application (NDA): 214719
✉ Email this page to a colleague
The generic ingredient in ERLOTINIB HYDROCHLORIDE is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Thirteen 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 |
Complete Access Available with Subscription