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Details for New Drug Application (NDA): 078454

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NDA 078454 describes MOEXIPRIL HYDROCHLORIDE, which is a drug marketed by Teva, Glenmark Generics, Paddock Llc, Apotex Inc, Glenmark Pharms, and Heritage Pharms Inc, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the MOEXIPRIL HYDROCHLORIDE profile page.

The generic ingredient in MOEXIPRIL HYDROCHLORIDE is hydrochlorothiazide; moexipril hydrochloride. There are thirty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; moexipril hydrochloride profile page.

Summary for NDA: 078454

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078454

Suppliers and Packaging for NDA: 078454

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
moexipril hydrochloride
TABLET;ORAL 078454 ANDA Physicians Total Care, Inc. 54868-4883 54868-4883-0 40 TABLET in 1 BOTTLE, PLASTIC (54868-4883-0)
moexipril hydrochloride
TABLET;ORAL 078454 ANDA Physicians Total Care, Inc. 54868-4883 54868-4883-1 20 TABLET in 1 BOTTLE, PLASTIC (54868-4883-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Jun 2, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jun 2, 2008TE:ABRLD: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.