Details for New Drug Application (NDA): 216342
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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 216342
Tradename: | ERLOTINIB HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | erlotinib hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 216342
Mechanism of Action | Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 216342
Suppliers and Packaging for NDA: 216342
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 216342 | ANDA | Aurobindo Pharma Limited | 59651-530 | 59651-530-03 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-530-03) |
ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 216342 | ANDA | Aurobindo Pharma Limited | 59651-530 | 59651-530-10 | 1 BLISTER PACK in 1 CARTON (59651-530-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Jun 22, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Jun 22, 2022 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Jun 22, 2022 | TE: | RLD: | No |
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