Details for New Drug Application (NDA): 214184
✉ Email this page to a colleague
The generic ingredient in PROPAFENONE HYDROCHLORIDE is propafenone hydrochloride. There are eleven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 214184
Tradename: | PROPAFENONE HYDROCHLORIDE |
Applicant: | Zydus Lifesciences |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 214184
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 214184 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-522 | 68382-522-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-522-05) |
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 214184 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-522 | 68382-522-14 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-522-14) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 225MG | ||||
Approval Date: | Apr 21, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 325MG | ||||
Approval Date: | Apr 21, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 425MG | ||||
Approval Date: | Apr 21, 2021 | TE: | AB | RLD: | No |
Complete Access Available with Subscription