Details for New Drug Application (NDA): 076392
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NDA 076392 describes MEFLOQUINE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma, Hikma Intl Pharms, Sandoz, and Us Army Walter Reed, and is included in five NDAs. It is available from three suppliers. Additional details are available on the MEFLOQUINE HYDROCHLORIDE profile page.
The generic ingredient in MEFLOQUINE HYDROCHLORIDE is mefloquine hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mefloquine hydrochloride profile page.
The generic ingredient in MEFLOQUINE HYDROCHLORIDE is mefloquine hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mefloquine hydrochloride profile page.
Summary for 076392
| Tradename: | MEFLOQUINE HYDROCHLORIDE |
| Applicant: | Barr |
| Ingredient: | mefloquine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076392
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEFLOQUINE HYDROCHLORIDE | mefloquine hydrochloride | TABLET;ORAL | 076392 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0171 | 0555-0171-78 | 25 BLISTER PACK in 1 CARTON (0555-0171-78) / 1 TABLET in 1 BLISTER PACK (0555-0171-88) |
| MEFLOQUINE HYDROCHLORIDE | mefloquine hydrochloride | TABLET;ORAL | 076392 | ANDA | A-S Medication Solutions | 50090-2396 | 50090-2396-0 | 1 BLISTER PACK in 1 CARTON (50090-2396-0) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Dec 29, 2003 | TE: | AB | RLD: | No | ||||
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