Details for New Drug Application (NDA): 021302
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The generic ingredient in ELIDEL 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 021302
Tradename: | ELIDEL |
Applicant: | Bausch |
Ingredient: | pimecrolimus |
Patents: | 0 |
Pharmacology for NDA: 021302
Mechanism of Action | Calcineurin Inhibitors |
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 | Bausch Health US, LLC | 0187-5100 | 0187-5100-01 | 1 TUBE in 1 CARTON (0187-5100-01) / 30 g in 1 TUBE |
ELIDEL | pimecrolimus | CREAM;TOPICAL | 021302 | NDA | Bausch Health US, LLC | 0187-5101 | 0187-5101-02 | 1 TUBE in 1 CARTON (0187-5101-02) / 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 |
Expired US Patents for NDA 021302
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | ELIDEL | pimecrolimus | CREAM;TOPICAL | 021302-001 | Dec 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | ELIDEL | pimecrolimus | CREAM;TOPICAL | 021302-001 | Dec 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | ELIDEL | pimecrolimus | CREAM;TOPICAL | 021302-001 | Dec 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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