Details for New Drug Application (NDA): 091211
✉ Email this page to a colleague
The generic ingredient in ATOVAQUONE AND PROGUANIL HYDROCHLORIDE is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
Summary for 091211
Tradename: | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | atovaquone; proguanil hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 091211
Mechanism of Action | Dihydrofolate Reductase Inhibitors |
Suppliers and Packaging for NDA: 091211
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 091211 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-393 | 43063-393-14 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-393-14) |
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 091211 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-393 | 43063-393-20 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-393-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG;100MG | ||||
Approval Date: | Jan 12, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 62.5MG;25MG | ||||
Approval Date: | Apr 6, 2015 | TE: | AB | RLD: | No |
Complete Access Available with Subscription