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Last Updated: October 17, 2021

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Details for New Drug Application (NDA): 090103

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NDA 090103 describes NIMODIPINE, which is a drug marketed by Bionpharma Inc, Heritage Pharms Inc, Sofgen Pharms, Sun Pharm Inds Inc, and Thepharmanetwork Llc, and is included in five NDAs. It is available from six 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. Seven suppliers are listed for this compound. Additional details are available on the nimodipine profile page.
Summary for 090103
Applicant:Thepharmanetwork Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 090103
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 090103
Suppliers and Packaging for NDA: 090103
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIMODIPINE nimodipine CAPSULE;ORAL 090103 ANDA McKesson Corporation dba SKY Packaging 63739-797 63739-797-33 3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-797-33) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NIMODIPINE nimodipine CAPSULE;ORAL 090103 ANDA Ascend Laboratories, LLC 67877-297 67877-297-30 30 CAPSULE, LIQUID FILLED in 1 PACKAGE (67877-297-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Apr 7, 2014TE:ABRLD:No

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