Details for New Drug Application (NDA): 073580
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NDA 073580 describes EMVERM, which is a drug marketed by Impax Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the EMVERM profile page.
The generic ingredient in EMVERM is mebendazole. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mebendazole profile page.
The generic ingredient in EMVERM is mebendazole. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mebendazole profile page.
Summary for 073580
| Tradename: | EMVERM |
| Applicant: | Impax Labs Inc |
| Ingredient: | mebendazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 073580
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EMVERM | mebendazole | TABLET, CHEWABLE;ORAL | 073580 | ANDA | Amneal Pharmaceuticals LLC | 64896-669 | 64896-669-30 | 1 BLISTER PACK in 1 CARTON (64896-669-30) / 1 TABLET, CHEWABLE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jan 4, 1995 | TE: | RLD: | No | |||||
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