Details for New Drug Application (NDA): 210300
✉ Email this page to a colleague
NDA 210300 describes ERLOTINIB HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Eugia Pharma, MSN, Natco Pharma Ltd, Rising, Shilpa, Sun Pharm, Teva Pharms Usa Inc, and Zydus Pharms, and is included in eleven NDAs. It is available from twelve 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
Summary for 210300
| Tradename: | ERLOTINIB HYDROCHLORIDE |
| Applicant: | Sun Pharm |
| Ingredient: | erlotinib hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210300
| Mechanism of Action | Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 210300
Suppliers and Packaging for NDA: 210300
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 210300 | ANDA | Sun Pharmaceutical Industries, Inc. | 63304-095 | 63304-095-11 | 3 BLISTER PACK in 1 CARTON (63304-095-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-095-31) |
| ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 210300 | ANDA | Sun Pharmaceutical Industries, Inc. | 63304-095 | 63304-095-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63304-095-30) |
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 | ||||
Complete Access Available with Subscription
