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Generated: May 26, 2017

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Details for New Drug Application (NDA): 076457

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NDA 076457 describes GANCICLOVIR, which is a drug marketed by Luitpold Pharms Inc, Exela Pharma Scs Llc, Par Sterile Products, Ranbaxy Labs Ltd, Fresenius Kabi Usa, and West-ward Pharms Int, and is included in six NDAs. It is available from five suppliers. There is one patent protecting this drug. Additional details are available on the GANCICLOVIR profile page.

The generic ingredient in GANCICLOVIR is ganciclovir . There are twenty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.

Summary for NDA: 076457

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 076457

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 076457

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANCICLOVIR
ganciclovir
CAPSULE;ORAL 076457 ANDA Ranbaxy Pharmaceuticals Inc. 63304-636 63304-636-10 1000 CAPSULE in 1 BOTTLE (63304-636-10)
GANCICLOVIR
ganciclovir
CAPSULE;ORAL 076457 ANDA Ranbaxy Pharmaceuticals Inc. 63304-636 63304-636-28 180 CAPSULE in 1 BOTTLE (63304-636-28)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength250MG
Approval Date:Jun 27, 2003TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength500MG
Approval Date:Jun 27, 2003TE:RLD:No


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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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