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Details for New Drug Application (NDA): 203791

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NDA 203791 describes SITAVIG, which is a drug marketed by Cipher Pharms Us and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the SITAVIG profile page.

The generic ingredient in SITAVIG is acyclovir. There are fifty-five drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

Summary for NDA: 203791

Cipher Pharms Us
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 203791

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 203791

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;BUCCAL 203791 NDA Cipher Pharmaceuticals US LLC 68712-049 68712-049-02 1 BLISTER PACK in 1 CARTON (68712-049-02) > 2 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;BUCCALStrength50MG
Approval Date:Apr 12, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 12, 2016
Regulatory Exclusivity Use:NEW PRODUCT
Patent:8,592,434Patent Expiration:Jun 16, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:8,747,896Patent Expiration:Jun 3, 2027Product Flag?YSubstance Flag?Delist Request?

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