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Generated: May 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077317

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NDA 077317 describes ISRADIPINE, which is a drug marketed by Watson Labs, Mylan Pharms Inc, and Elite Labs Inc, and is included in three NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the isradipine profile page.

Summary for NDA: 077317

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077317

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 077317

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 077317 ANDA Actavis Pharma, Inc. 16252-539 16252-539-01 100 CAPSULE in 1 BOTTLE (16252-539-01)
CAPSULE;ORAL 077317 ANDA Actavis Pharma, Inc. 16252-540 16252-540-01 100 CAPSULE in 1 BOTTLE (16252-540-01)

Summary for product number 001

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

Summary for product number 002

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

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