DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 075998
The generic ingredient in PROPAFENONE HYDROCHLORIDE is propafenone hydrochloride. There are eleven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 075998
Tradename: | PROPAFENONE HYDROCHLORIDE |
Applicant: | Sun Pharm Industries |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Therapeutic Class: | Cardiovascular Agents |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075998
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 075998 | ANDA | Mylan Institutional Inc. | 51079-996 | N | 51079-996-20 |
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 075998 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-551 | N | 53489-551-01 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Nov 29, 2001 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 225MG | ||||
Approval Date: | Nov 29, 2001 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Nov 29, 2001 | TE: | AB | RLD: | No |
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