Details for New Drug Application (NDA): 076523
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The generic ingredient in MEFLOQUINE HYDROCHLORIDE is mefloquine hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mefloquine hydrochloride profile page.
Summary for 076523
Tradename: | MEFLOQUINE HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | mefloquine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 076523
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEFLOQUINE HYDROCHLORIDE | mefloquine hydrochloride | TABLET;ORAL | 076523 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0025 | 0054-0025-11 | 1 BOTTLE in 1 CARTON (0054-0025-11) / 25 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Oct 1, 2004 | TE: | AB | RLD: | No |
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