Details for New Drug Application (NDA): 078540
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NDA 078540 describes PROPAFENONE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Sinotherapeutics Inc, Strides Pharma Intl, 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 fifteen 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. Fifteen 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. Fifteen 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 Intl |
| Ingredient: | propafenone hydrochloride |
| Patents: | 0 |
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 | Strides Pharma Science Limited | 64380-184 | 64380-184-01 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-184-01) |
| PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078540 | ANDA | Strides Pharma Science Limited | 64380-184 | 64380-184-02 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-184-02) |
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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