Details for New Drug Application (NDA): 076175
NDA 076175 describes MEFLOQUINE HYDROCHLORIDE, which is a drug marketed by Barr, Chartwell Rx, Hikma, Hikma Intl Pharms, 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 is one drug master file entry 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 is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the mefloquine hydrochloride profile page.
Summary for 076175
| Tradename: | MEFLOQUINE HYDROCHLORIDE |
| Applicant: | Chartwell Rx |
| Ingredient: | mefloquine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076175
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEFLOQUINE HYDROCHLORIDE | mefloquine hydrochloride | TABLET;ORAL | 076175 | ANDA | Chartwell RX, LLC | 62135-973 | 62135-973-11 | 5 TABLET in 1 BOTTLE (62135-973-11) |
| MEFLOQUINE HYDROCHLORIDE | mefloquine hydrochloride | TABLET;ORAL | 076175 | ANDA | Chartwell RX, LLC | 62135-973 | 62135-973-25 | 25 TABLET in 1 BOTTLE (62135-973-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Feb 20, 2002 | TE: | AB | RLD: | No | ||||
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