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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 040733


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NDA 040733 describes DIPYRIDAMOLE, which is a drug marketed by Chartwell Injectable, Dr Reddys, Eugia Pharma Speclts, Fresenius Kabi Usa, Hikma, Hospira, Ani Pharms, Barr, Chartwell Rx, 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 nine 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. Nine suppliers are listed for this compound. Additional details are available on the dipyridamole profile page.
Summary for 040733
Tradename:DIPYRIDAMOLE
Applicant:Rising
Ingredient:dipyridamole
Patents:0
Pharmacology for NDA: 040733
Physiological EffectDecreased Platelet Aggregation
Medical Subject Heading (MeSH) Categories for 040733
Suppliers and Packaging for NDA: 040733
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPYRIDAMOLE dipyridamole TABLET;ORAL 040733 ANDA Rising Pharmaceuticals, Inc. 64980-133 64980-133-01 100 TABLET, FILM COATED in 1 BOTTLE (64980-133-01)
DIPYRIDAMOLE dipyridamole TABLET;ORAL 040733 ANDA Rising Pharmaceuticals, Inc. 64980-133 64980-133-10 1000 TABLET, FILM COATED in 1 BOTTLE (64980-133-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Feb 13, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 13, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Feb 13, 2007TE:ABRLD:No

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