Details for New Drug Application (NDA): 078540
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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 078540
Tradename: | PROPAFENONE HYDROCHLORIDE |
Applicant: | Strides Pharma |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078540
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078540 | ANDA | Par Pharmaceutical, Inc. | 49884-113 | 49884-113-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-113-01) |
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078540 | ANDA | Par Pharmaceutical, Inc. | 49884-113 | 49884-113-02 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-113-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 225MG | ||||
Approval Date: | Oct 18, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 325MG | ||||
Approval Date: | Oct 18, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 425MG | ||||
Approval Date: | Oct 18, 2010 | TE: | AB | RLD: | No |
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