Details for New Drug Application (NDA): 207116
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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 207116
| Tradename: | MUPIROCIN |
| Applicant: | Sun Pharma Canada |
| Ingredient: | mupirocin calcium |
| Patents: | 0 |
Pharmacology for NDA: 207116
| Mechanism of Action | RNA Synthetase Inhibitors |
Suppliers and Packaging for NDA: 207116
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MUPIROCIN | mupirocin calcium | CREAM;TOPICAL | 207116 | ANDA | NORTHSTAR RX LLC | 16714-055 | 16714-055-01 | 1 TUBE in 1 CARTON (16714-055-01) / 15 g in 1 TUBE |
| MUPIROCIN | mupirocin calcium | CREAM;TOPICAL | 207116 | ANDA | NORTHSTAR RX LLC | 16714-055 | 16714-055-02 | 1 TUBE in 1 CARTON (16714-055-02) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | EQ 2% BASE | ||||
| Approval Date: | Apr 27, 2020 | TE: | AB | RLD: | No | ||||
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