Details for New Drug Application (NDA): 075938
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NDA 075938 describes PROPAFENONE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Sinotherapeutics Inc, Strides Pharma, Twi Pharms, Upsher Smith Labs, Watson Labs Inc, Zydus Lifesciences, Ani Pharms, Aurobindo Pharma, Nesher Pharms, Sun Pharm Industries, and Watson Labs, and is included in sixteen NDAs. It is available from eighteen suppliers. Additional details are available on the PROPAFENONE HYDROCHLORIDE profile page.
The generic ingredient in PROPAFENONE HYDROCHLORIDE is propafenone hydrochloride. There are eleven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
The generic ingredient in PROPAFENONE HYDROCHLORIDE is propafenone hydrochloride. There are eleven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 075938
| Tradename: | PROPAFENONE HYDROCHLORIDE |
| Applicant: | Strides Pharma |
| Ingredient: | propafenone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075938
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 075938 | ANDA | American Health Packaging | 60687-709 | 60687-709-01 | 100 BLISTER PACK in 1 CARTON (60687-709-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-709-11) |
| PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 075938 | ANDA | Strides Pharma Science Limited | 64380-163 | 64380-163-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-163-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Oct 17, 2002 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 225MG | ||||
| Approval Date: | Oct 17, 2002 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Oct 17, 2002 | TE: | AB | RLD: | No | ||||
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