Details for New Drug Application (NDA): 212368
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The generic ingredient in PENCICLOVIR 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 212368
Tradename: | PENCICLOVIR |
Applicant: | Padagis Israel |
Ingredient: | penciclovir |
Patents: | 0 |
Pharmacology for NDA: 212368
Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 212368
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PENCICLOVIR | penciclovir | CREAM;TOPICAL | 212368 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-440 | 45802-440-75 | 1 TUBE in 1 CARTON (45802-440-75) / 5 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
Approval Date: | Sep 27, 2024 | TE: | AB | RLD: | No |
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