Details for New Drug Application (NDA): 022483
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NDA 022483 describes ZYCLARA, which is a drug marketed by Bausch and is included in one NDA. It is available from four suppliers. There are ten patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ZYCLARA profile page.
The generic ingredient in ZYCLARA is imiquimod. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the imiquimod profile page.
The generic ingredient in ZYCLARA is imiquimod. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the imiquimod profile page.
Pharmacology for NDA: 022483
| Mechanism of Action | Interferon Inducers |
| Physiological Effect | Increased Cytokine Activity Increased Cytokine Production |
Suppliers and Packaging for NDA: 022483
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYCLARA | imiquimod | CREAM;TOPICAL | 022483 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3133 | 0093-3133-31 | 1 BOTTLE, PUMP in 1 CARTON (0093-3133-31) / 7.5 g in 1 BOTTLE, PUMP |
| ZYCLARA | imiquimod | CREAM;TOPICAL | 022483 | NDA AUTHORIZED GENERIC | Bryant Ranch Prepack | 63629-8818 | 63629-8818-1 | 1 BOTTLE, PUMP in 1 CARTON (63629-8818-1) / 7.5 g in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 3.75% | ||||
| Approval Date: | Mar 25, 2010 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 11, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACTINIC KERATOSIS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 18, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF GENITAL WARTS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 18, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PERIANAL WARTS | ||||||||
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