Details for New Drug Application (NDA): 216342
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NDA 216342 describes ERLOTINIB HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Chartwell Rx, Eugia Pharma, Hetero Labs Ltd V, MSN, Natco Pharma Ltd, Rising, Shilpa, Sun Pharm, Teva Pharms Usa Inc, and Zydus Pharms, and is included in thirteen NDAs. It is available from ten suppliers. Additional details are available on the ERLOTINIB HYDROCHLORIDE profile page.
The generic ingredient in ERLOTINIB HYDROCHLORIDE is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
The generic ingredient in ERLOTINIB HYDROCHLORIDE is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Eleven 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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