Details for New Drug Application (NDA): 208488
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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 208488
Tradename: | ERLOTINIB HYDROCHLORIDE |
Applicant: | Natco Pharma Ltd |
Ingredient: | erlotinib hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208488
Mechanism of Action | Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 208488
Suppliers and Packaging for NDA: 208488
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 208488 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-891 | 51991-891-33 | 30 TABLET, FILM COATED in 1 BOTTLE (51991-891-33) |
ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 208488 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-892 | 51991-892-33 | 30 TABLET, FILM COATED in 1 BOTTLE (51991-892-33) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Nov 5, 2019 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Nov 5, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Nov 5, 2019 | TE: | RLD: | No |
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