Details for New Drug Application (NDA): 209345
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NDA 209345 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 209345
| Tradename: | PIMECROLIMUS |
| Applicant: | Actavis Labs Ut Inc |
| Ingredient: | pimecrolimus |
| Patents: | 0 |
Pharmacology for NDA: 209345
| Mechanism of Action | Calcineurin Inhibitors |
Suppliers and Packaging for NDA: 209345
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIMECROLIMUS | pimecrolimus | CREAM;TOPICAL | 209345 | ANDA | Actavis Pharma, Inc. | 0591-2944 | 0591-2944-30 | 30 g in 1 TUBE (0591-2944-30) |
| PIMECROLIMUS | pimecrolimus | CREAM;TOPICAL | 209345 | ANDA | Actavis Pharma, Inc. | 0591-2944 | 0591-2944-60 | 60 g in 1 TUBE (0591-2944-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Dec 27, 2018 | TE: | AB | RLD: | No | ||||
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