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Generated: November 19, 2018

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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 Epi Hlth and is included in one NDA. It is available from two suppliers. 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-six drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the acyclovir profile page.
Summary for 203791
Tradename:SITAVIG
Applicant:Epi Hlth
Ingredient:acyclovir
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 203791
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 203791
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
SITAVIG acyclovir TABLET;BUCCAL 203791 NDA EPI Health, Inc 71403-049 71403-049-01 1 BLISTER PACK in 1 CARTON (71403-049-01) > 2 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;BUCCALStrength50MG
Approval Date:Apr 12, 2013TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 16, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HERPES LABIALIS
Patent:➤ Try a Free TrialPatent Expiration:Jun 3, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HERPES LABIALIS
Patent:➤ Try a Free TrialPatent Expiration:Mar 23, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HERPES LABIALIS

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