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Generated: September 21, 2017

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Details for New Drug Application (NDA): 079135

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NDA 079135 describes TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, which is a drug marketed by Glenmark Generics and is included in one NDA. It is available from one supplier. Additional details are available on the TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE profile page.

The generic ingredient in TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE is trandolapril; verapamil hydrochloride. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the trandolapril; verapamil hydrochloride profile page.

Summary for NDA: 079135

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 079135

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
trandolapril; verapamil hydrochloride
TABLET, EXTENDED RELEASE;ORAL 079135 ANDA Glenmark Pharmaceuticals Inc., USA 68462-294 68462-294-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-294-01)
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
trandolapril; verapamil hydrochloride
TABLET, EXTENDED RELEASE;ORAL 079135 ANDA Glenmark Pharmaceuticals Inc., USA 68462-294 68462-294-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-294-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2MG;180MG
Approval Date:May 26, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2MG;240MG
Approval Date:May 26, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength4MG;240MG
Approval Date:May 5, 2010TE:ABRLD:No


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US Army
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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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