Details for New Drug Application (NDA): 213076
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NDA 213076 describes MUPIROCIN, which is a drug marketed by Alembic, Amneal, Encube, Glenmark Pharms Inc, Padagis Israel, Taro, Fougera Pharms, Glenmark Pharms, and Teva, and is included in eleven NDAs. It is available from twenty-five suppliers. Additional details are available on the MUPIROCIN profile page.
The generic ingredient in MUPIROCIN is mupirocin. There are sixteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the mupirocin profile page.
The generic ingredient in MUPIROCIN is mupirocin. There are sixteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the mupirocin profile page.
Summary for 213076
| Tradename: | MUPIROCIN |
| Applicant: | Encube |
| Ingredient: | mupirocin calcium |
| Patents: | 0 |
Pharmacology for NDA: 213076
| Mechanism of Action | RNA Synthetase Inhibitors |
Suppliers and Packaging for NDA: 213076
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MUPIROCIN | mupirocin calcium | CREAM;TOPICAL | 213076 | ANDA | Encube Ethicals Private Limited | 21922-029 | 21922-029-04 | 1 TUBE in 1 CARTON (21922-029-04) / 15 g in 1 TUBE |
| MUPIROCIN | mupirocin calcium | CREAM;TOPICAL | 213076 | ANDA | Encube Ethicals Private Limited | 21922-029 | 21922-029-05 | 1 TUBE in 1 CARTON (21922-029-05) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | EQ 2% BASE | ||||
| Approval Date: | Aug 31, 2021 | TE: | AB | RLD: | No | ||||
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