Details for New Drug Application (NDA): 215839
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The generic ingredient in DOCOSANOL is docosanol. There are five drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the docosanol profile page.
Summary for 215839
Tradename: | DOCOSANOL |
Applicant: | Alembic |
Ingredient: | docosanol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 215839
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOCOSANOL | docosanol | CREAM;TOPICAL | 215839 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0353 | 0713-0353-02 | 1 TUBE in 1 CARTON (0713-0353-02) / 2 g in 1 TUBE |
DOCOSANOL | docosanol | CREAM;TOPICAL | 215839 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0353 | 0713-0353-62 | 1 BOTTLE, PUMP in 1 CARTON (0713-0353-62) / 2 g in 1 BOTTLE, PUMP |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;TOPICAL | Strength | 10% | ||||
Approval Date: | May 3, 2022 | TE: | RLD: | No |
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