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Details for New Drug Application (NDA): 074483

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NDA 074483 describes CAPTOPRIL, which is a drug marketed by Hikma Intl Pharms, Vintage Pharms Llc, Sandoz, Teva, Dava Pharms Inc, Wockhardt, G And W Labs Inc, Mylan, Apotex, Purepac Pharm, Egis Pharms, Watson Labs, Apothecon, Prinston Inc, Stason, Par Pharm, and Ivax Sub Teva Pharms, and is included in twenty-eight NDAs. It is available from twenty-eight suppliers. Additional details are available on the CAPTOPRIL profile page.

The generic ingredient in CAPTOPRIL is captopril; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the captopril; hydrochlorothiazide profile page.

Summary for NDA: 074483

G And W Labs Inc
Therapeutic Class:Cardiovascular Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG
Approval Date:Feb 13, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Feb 13, 1996TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Feb 13, 1996TE: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.