Details for New Drug Application (NDA): 020629
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The generic ingredient in DENAVIR is penciclovir. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the penciclovir profile page.
Summary for 020629
Tradename: | DENAVIR |
Applicant: | Mylan |
Ingredient: | penciclovir |
Patents: | 0 |
Pharmacology for NDA: 020629
Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 020629
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DENAVIR | penciclovir | CREAM;TOPICAL | 020629 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-0896 | 0378-0896-55 | 1 TUBE in 1 CARTON (0378-0896-55) / 5 g in 1 TUBE |
DENAVIR | penciclovir | CREAM;TOPICAL | 020629 | NDA | Mylan Pharmaceuticals Inc. | 0378-9720 | 0378-9720-55 | 1 TUBE in 1 CARTON (0378-9720-55) / 5 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
Approval Date: | Sep 24, 1996 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020629
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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