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Last Updated: August 4, 2020

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Details for New Drug Application (NDA): 074505

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NDA 074505 describes CAPTOPRIL, which is a drug marketed by Ajanta Pharma Ltd, Apothecon, Boscogen, Corepharma, Cosette, Dava Pharms Inc, Egis Pharms, G And W Labs Inc, Hikma Intl Pharms, Mylan, Oxford Pharms, Par Pharm, Prinston Inc, Purepac Pharm, Sandoz, Seton Pharms, Teva, Watson Labs, Wockhardt Ltd, Yaopharma Co Ltd, Ivax Sub Teva Pharms, and Vintage Pharms Llc, and is included in thirty NDAs. It is available from thirteen suppliers. Additional details are available on the CAPTOPRIL profile page.

The generic ingredient in CAPTOPRIL is captopril; hydrochlorothiazide. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the captopril; hydrochlorothiazide profile page.
Summary for 074505
Tradename:CAPTOPRIL
Applicant:Hikma Intl Pharms
Ingredient:captopril
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074505
Medical Subject Heading (MeSH) Categories for 074505
Suppliers and Packaging for NDA: 074505
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPTOPRIL captopril TABLET;ORAL 074505 ANDA Hikma Pharmaceuticals USA Inc. 0143-1171 0143-1171-01 100 TABLET in 1 BOTTLE (0143-1171-01)
CAPTOPRIL captopril TABLET;ORAL 074505 ANDA Hikma Pharmaceuticals USA Inc. 0143-1171 0143-1171-10 1000 TABLET in 1 BOTTLE (0143-1171-10)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 13, 1996TE:ABRLD:No

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