Details for New Drug Application (NDA): 212710
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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 212710
Tradename: | PENCICLOVIR |
Applicant: | Teva Pharms Usa |
Ingredient: | penciclovir |
Patents: | 0 |
Pharmacology for NDA: 212710
Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 212710
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PENCICLOVIR | penciclovir | CREAM;TOPICAL | 212710 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3186 | 0093-3186-20 | 1 TUBE in 1 CARTON (0093-3186-20) / 5 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
Approval Date: | Nov 9, 2022 | TE: | AB | RLD: | No |
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