Details for New Drug Application (NDA): 202362
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NDA 202362 describes ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, which is a drug marketed by Glenmark Pharms Ltd and Mylan and is included in two NDAs. It is available from eight suppliers. Additional details are available on the ATOVAQUONE AND PROGUANIL HYDROCHLORIDE profile page.
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.
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 202362
| Tradename: | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE |
| Applicant: | Mylan |
| Ingredient: | atovaquone; proguanil hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 202362
| Mechanism of Action | Dihydrofolate Reductase Inhibitors |
Suppliers and Packaging for NDA: 202362
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 202362 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4160 | 0378-4160-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-01) |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 202362 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4162 | 0378-4162-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4162-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 62.5MG;25MG | ||||
| Approval Date: | May 27, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG;100MG | ||||
| Approval Date: | May 27, 2014 | TE: | AB | RLD: | No | ||||
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