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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216937


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NDA 216937 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 216937
Tradename:NIMODIPINE
Applicant:Annora Pharma
Ingredient:nimodipine
Patents:0
Pharmacology for NDA: 216937
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 216937
Suppliers and Packaging for NDA: 216937
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIMODIPINE nimodipine SOLUTION;ORAL 216937 ANDA Camber Pharmaceuticals, Inc. 31722-039 31722-039-47 473 mL in 1 BOTTLE (31722-039-47)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength3MG/ML
Approval Date:Jul 9, 2024TE:RLD:No

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