Details for New Drug Application (NDA): 217090
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The generic ingredient in DOCOSANOL is docosanol. There are five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the docosanol profile page.
Summary for 217090
Tradename: | DOCOSANOL |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | docosanol |
Patents: | 0 |
Suppliers and Packaging for NDA: 217090
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOCOSANOL | docosanol | CREAM;TOPICAL | 217090 | ANDA | KROGER COMPANY | 30142-286 | 30142-286-02 | 1 TUBE in 1 PACKAGE (30142-286-02) / 2 g in 1 TUBE |
DOCOSANOL | docosanol | CREAM;TOPICAL | 217090 | ANDA | KROGER COMPANY | 30142-286 | 30142-286-04 | 2 TUBE in 1 PACKAGE (30142-286-04) / 2 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;TOPICAL | Strength | 10% | ||||
Approval Date: | Mar 1, 2024 | TE: | RLD: | No |
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