Details for New Drug Application (NDA): 091059
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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 091059
Tradename: | ERLOTINIB HYDROCHLORIDE |
Applicant: | Teva Pharms Usa Inc |
Ingredient: | erlotinib hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 091059
Mechanism of Action | Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091059
Suppliers and Packaging for NDA: 091059
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 091059 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7662 | 0093-7662-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-7662-56) |
ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 091059 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7663 | 0093-7663-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-7663-56) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Nov 9, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Aug 28, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Aug 28, 2015 | TE: | AB | RLD: | No |
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