Details for New Drug Application (NDA): 021302
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NDA 021302 describes ELIDEL, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the ELIDEL profile page.
The generic ingredient in ELIDEL is pimecrolimus. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.
The generic ingredient in ELIDEL is pimecrolimus. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.
Summary for 021302
| Tradename: | ELIDEL |
| Applicant: | Bausch |
| Ingredient: | pimecrolimus |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021302
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELIDEL | pimecrolimus | CREAM;TOPICAL | 021302 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-110 | 68682-110-01 | 1 TUBE in 1 CARTON (68682-110-01) / 30 g in 1 TUBE |
| ELIDEL | pimecrolimus | CREAM;TOPICAL | 021302 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-111 | 68682-111-02 | 1 TUBE in 1 CARTON (68682-111-02) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Dec 13, 2001 | TE: | AB | RLD: | Yes | ||||
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