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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 076740


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NDA 076740 describes NIMODIPINE, which is a drug marketed by Bionpharma, Heritage, Sofgen Pharms, Sun Pharm Inds Inc, Thepharmanetwork Llc, and Annora Pharma, and is included in six NDAs. It is available from three suppliers. Additional details are available on the NIMODIPINE profile page.

The generic ingredient in NIMODIPINE is nimodipine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nimodipine profile page.
Summary for 076740
Tradename:NIMODIPINE
Applicant:Bionpharma
Ingredient:nimodipine
Patents:0
Pharmacology for NDA: 076740
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 076740
Suppliers and Packaging for NDA: 076740
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIMODIPINE nimodipine CAPSULE;ORAL 076740 ANDA BIONPHARMA INC. 69452-209 69452-209-13 3 BLISTER PACK in 1 CARTON (69452-209-13) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NIMODIPINE nimodipine CAPSULE;ORAL 076740 ANDA BIONPHARMA INC. 69452-209 69452-209-20 10 BLISTER PACK in 1 CARTON (69452-209-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Jan 17, 2008TE:ABRLD:No

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