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Details for New Drug Application (NDA): 203340

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NDA 203340 describes NYMALIZE, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the NYMALIZE profile page.

The generic ingredient in NYMALIZE is nimodipine. There are seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the nimodipine profile page.

Summary for NDA: 203340

Arbor Pharms Llc
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 203340

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 203340

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL 203340 NDA Arbor Pharmaceuticals 24338-200 24338-200-12 12 PACKAGE in 1 CARTON (24338-200-12) > 1 CUP, UNIT-DOSE in 1 PACKAGE (24338-200-20) > 20 mL in 1 CUP, UNIT-DOSE
SOLUTION;ORAL 203340 NDA Arbor Pharmaceuticals 24338-200 24338-200-16 473 mL in 1 BOTTLE (24338-200-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength60MG/20ML
Approval Date:May 10, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:May 10, 2020
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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