Details for New Drug Application (NDA): 211871
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NDA 211871 describes PODOFILOX, which is a drug marketed by Padagis Us and Bausch And Lomb Inc and is included in three NDAs. It is available from one supplier. Additional details are available on the PODOFILOX profile page.
The generic ingredient in PODOFILOX is podofilox. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the podofilox profile page.
The generic ingredient in PODOFILOX is podofilox. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the podofilox profile page.
Summary for 211871
| Tradename: | PODOFILOX |
| Applicant: | Padagis Us |
| Ingredient: | podofilox |
| Patents: | 0 |
Pharmacology for NDA: 211871
| Physiological Effect | Decreased Mitosis |
Suppliers and Packaging for NDA: 211871
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PODOFILOX | podofilox | GEL;TOPICAL | 211871 | ANDA | Padagis US LLC | 0574-0621 | 0574-0621-05 | 3.5 g in 1 TUBE, WITH APPLICATOR (0574-0621-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.5% | ||||
| Approval Date: | Nov 22, 2023 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jun 10, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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