Details for New Drug Application (NDA): 040542
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NDA 040542 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.
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 040542
| Tradename: | DIPYRIDAMOLE |
| Applicant: | Oxford Pharms |
| Ingredient: | dipyridamole |
| Patents: | 0 |
Pharmacology for NDA: 040542
| Physiological Effect | Decreased Platelet Aggregation |
Medical Subject Heading (MeSH) Categories for 040542
Suppliers and Packaging for NDA: 040542
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIPYRIDAMOLE | dipyridamole | TABLET;ORAL | 040542 | ANDA | Oxford Pharmaceuticals, LLC | 69584-181 | 69584-181-10 | 100 TABLET, FILM COATED in 1 BOTTLE (69584-181-10) |
| DIPYRIDAMOLE | dipyridamole | TABLET;ORAL | 040542 | ANDA | Oxford Pharmaceuticals, LLC | 69584-182 | 69584-182-10 | 100 TABLET, FILM COATED in 1 BOTTLE (69584-182-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Apr 21, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Apr 21, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Apr 21, 2006 | TE: | AB | RLD: | No | ||||
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