Product NDC: | 54868-6393 |
Proprietary Name: | Atovaquone and Proguanil Hydrochloride |
Non Proprietary Name: | Atovaquone and Proguanil Hydrochloride |
Active Ingredient(s): | 250; 100 mg/1; mg/1 & nbsp; Atovaquone and Proguanil Hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54868-6393 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091211 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130123 |
Package NDC: | 54868-6393-0 |
Package Description: | 2 BLISTER PACK in 1 CARTON (54868-6393-0) > 12 TABLET, FILM COATED in 1 BLISTER PACK |
NDC Code | 54868-6393-0 |
Proprietary Name | Atovaquone and Proguanil Hydrochloride |
Package Description | 2 BLISTER PACK in 1 CARTON (54868-6393-0) > 12 TABLET, FILM COATED in 1 BLISTER PACK |
Product NDC | 54868-6393 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Atovaquone and Proguanil Hydrochloride |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20130123 |
Marketing Category Name | ANDA |
Labeler Name | Physicians Total Care, Inc. |
Substance Name | ATOVAQUONE; PROGUANIL HYDROCHLORIDE |
Strength Number | 250; 100 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] |