Details for New Drug Application (NDA): 212928
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The generic ingredient in PROPAFENONE HYDROCHLORIDE is propafenone hydrochloride. There are eleven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 212928
Tradename: | PROPAFENONE HYDROCHLORIDE |
Applicant: | Twi Pharms |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 212928
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 212928 | ANDA | Golden State Medical Supply, Inc. | 51407-477 | 51407-477-60 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-477-60) |
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 212928 | ANDA | Golden State Medical Supply, Inc. | 51407-478 | 51407-478-60 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-478-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 225MG | ||||
Approval Date: | Jun 18, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 325MG | ||||
Approval Date: | Jun 18, 2020 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 425MG | ||||
Approval Date: | Jun 18, 2020 | TE: | RLD: | No |
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