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Details for New Drug Application (NDA): 203803
The generic ingredient in PROPAFENONE HYDROCHLORIDE is propafenone hydrochloride. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 203803
Tradename: | PROPAFENONE HYDROCHLORIDE |
Applicant: | Mylan Pharms Inc |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Therapeutic Class: | Cardiovascular Agents |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203803
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 203803 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1258 | N | 0378-1258-91 |
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 203803 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1259 | N | 0378-1259-91 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 225MG | ||||
Approval Date: | Apr 29, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 325MG | ||||
Approval Date: | Apr 29, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 425MG | ||||
Approval Date: | Apr 29, 2016 | TE: | AB | RLD: | No |
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