Details for New Drug Application (NDA): 211769
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NDA 211769 describes PIMECROLIMUS, which is a drug marketed by Actavis Labs Ut Inc and Glenmark Pharms Ltd and is included in two NDAs. It is available from two suppliers. Additional details are available on the PIMECROLIMUS profile page.
The generic ingredient in PIMECROLIMUS is pimecrolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.
The generic ingredient in PIMECROLIMUS is pimecrolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.
Summary for 211769
| Tradename: | PIMECROLIMUS |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | pimecrolimus |
| Patents: | 0 |
Pharmacology for NDA: 211769
| Mechanism of Action | Calcineurin Inhibitors |
Suppliers and Packaging for NDA: 211769
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIMECROLIMUS | pimecrolimus | CREAM;TOPICAL | 211769 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-609 | 68462-609-35 | 1 TUBE in 1 CARTON (68462-609-35) / 30 g in 1 TUBE |
| PIMECROLIMUS | pimecrolimus | CREAM;TOPICAL | 211769 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-609 | 68462-609-65 | 1 TUBE in 1 CARTON (68462-609-65) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Aug 29, 2019 | TE: | AB | RLD: | No | ||||
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