Details for New Drug Application (NDA): 211960
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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 211960
Tradename: | ERLOTINIB HYDROCHLORIDE |
Applicant: | Shilpa |
Ingredient: | erlotinib hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 211960
Mechanism of Action | Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 211960
Suppliers and Packaging for NDA: 211960
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 211960 | ANDA | Areva Pharmaceuticals | 59923-725 | 59923-725-30 | 1 BOTTLE in 1 BOX (59923-725-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 211960 | ANDA | Areva Pharmaceuticals | 59923-726 | 59923-726-30 | 1 BOTTLE in 1 BOX (59923-726-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Nov 5, 2019 | TE: | AB | 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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Nov 5, 2019 | TE: | AB | RLD: | No |
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