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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 077317


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NDA 077317 describes ISRADIPINE, which is a drug marketed by Elite Labs Inc, Watson Labs Teva, and Norvium Bioscience, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ISRADIPINE profile page.

The generic ingredient in ISRADIPINE is isradipine. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the isradipine profile page.
Summary for 077317
Tradename:ISRADIPINE
Applicant:Watson Labs Teva
Ingredient:isradipine
Patents:0
Pharmacology for NDA: 077317
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 077317
Suppliers and Packaging for NDA: 077317
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISRADIPINE isradipine CAPSULE;ORAL 077317 ANDA Actavis Pharma, Inc. 16252-539 16252-539-01 100 CAPSULE in 1 BOTTLE (16252-539-01)
ISRADIPINE isradipine CAPSULE;ORAL 077317 ANDA Actavis Pharma, Inc. 16252-540 16252-540-01 100 CAPSULE in 1 BOTTLE (16252-540-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jan 5, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jan 5, 2006TE:ABRLD:No

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