Details for New Drug Application (NDA): 210339
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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 210339
Tradename: | PROPAFENONE HYDROCHLORIDE |
Applicant: | Sinotherapeutics Inc |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 210339
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210339 | ANDA | Vitruvias Therapeutics | 69680-130 | 69680-130-60 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-60) |
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210339 | ANDA | Vitruvias Therapeutics | 69680-130 | 69680-130-92 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-92) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 225MG | ||||
Approval Date: | Jan 4, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 325MG | ||||
Approval Date: | Jan 4, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 425MG | ||||
Approval Date: | Jan 4, 2019 | TE: | AB | RLD: | No |
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