Details for New Drug Application (NDA): 216981
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NDA 216981 describes PENCICLOVIR, which is a drug marketed by Padagis Israel, Teva Pharms Usa, and Torrent, and is included in three NDAs. It is available from three 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the penciclovir profile page.
Summary for 216981
| Tradename: | PENCICLOVIR |
| Applicant: | Torrent |
| Ingredient: | penciclovir |
| Patents: | 0 |
Pharmacology for NDA: 216981
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 216981
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENCICLOVIR | penciclovir | CREAM;TOPICAL | 216981 | ANDA | Torrent Pharmaceuticals Limited | 13668-661 | 13668-661-10 | 1 TUBE in 1 CARTON (13668-661-10) / 5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Aug 7, 2023 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 28, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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