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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-two suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

Summary for NDA: 203791

Tradename:
SITAVIG
Applicant:
Cipher Pharms Us
Ingredient:
acyclovir
Patents:3
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
SITAVIG
acyclovir
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?
Patented Use:TREATMENT OF HERPES LABIALIS
Patent:8,747,896Patent Expiration:Jun 3, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HERPES LABIALIS


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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