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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 074521


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NDA 074521 describes DIPYRIDAMOLE, which is a drug marketed by Chartwell Injectable, Dr Reddys, Eugia Pharma Speclts, Fresenius Kabi Usa, Hikma, Hospira, Ani Pharms, Barr, Genus, Glenmark Generics, Impax Labs, Oxford Pharms, Purepac Pharm, Rising, Watson Labs, and Zydus Pharms Usa Inc, and is included in twenty-two NDAs. It is available from eleven suppliers. Additional details are available on the DIPYRIDAMOLE profile page.

The generic ingredient in DIPYRIDAMOLE is dipyridamole. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dipyridamole profile page.
Summary for 074521
Tradename:DIPYRIDAMOLE
Applicant:Hikma
Ingredient:dipyridamole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074521
Physiological EffectDecreased Platelet Aggregation
Medical Subject Heading (MeSH) Categories for 074521
Suppliers and Packaging for NDA: 074521
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPYRIDAMOLE dipyridamole INJECTABLE;INJECTION 074521 ANDA Henry Schein, Inc. 0404-9852 0404-9852-10 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9852-10) / 10 mL in 1 VIAL, SINGLE-DOSE
DIPYRIDAMOLE dipyridamole INJECTABLE;INJECTION 074521 ANDA Hikma Pharmaceuticals USA Inc. 0641-2569 0641-2569-44 5 VIAL in 1 CARTON (0641-2569-44) / 10 mL in 1 VIAL (0641-2569-41)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:Oct 18, 1996TE:APRLD:No

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