Details for New Drug Application (NDA): 212368
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NDA 212368 describes PENCICLOVIR, which is a drug marketed by Amneal, Padagis Israel, Teva Pharms Usa, and Torrent, and is included in four NDAs. It is available from four suppliers. Additional details are available on the PENCICLOVIR profile page.
The generic ingredient in PENCICLOVIR is penciclovir. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the penciclovir profile page.
The generic ingredient in PENCICLOVIR is penciclovir. There are three drug master file entries for this compound. Five 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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