Details for New Drug Application (NDA): 075600
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NDA 075600 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the podofilox profile page.
Summary for 075600
| Tradename: | PODOFILOX |
| Applicant: | Padagis Us |
| Ingredient: | podofilox |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075600
| Physiological Effect | Decreased Mitosis |
Suppliers and Packaging for NDA: 075600
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PODOFILOX | podofilox | SOLUTION;TOPICAL | 075600 | ANDA | Padagis US LLC | 0574-0611 | 0574-0611-05 | 1 BOTTLE, GLASS in 1 CARTON (0574-0611-05) / 3.5 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.5% | ||||
| Approval Date: | Jan 29, 2002 | TE: | AT | RLD: | No | ||||
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