Details for New Drug Application (NDA): 040782
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NDA 040782 describes DIPYRIDAMOLE, which is a drug marketed by Chartwell Injectable, Dr Reddys, Eugia Pharma Speclts, Fresenius Kabi Usa, Hikma, Hospira, Ani Pharms, Barr, Barr Labs, 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 eight 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the dipyridamole profile page.
Summary for 040782
| Tradename: | DIPYRIDAMOLE |
| Applicant: | Impax Labs |
| Ingredient: | dipyridamole |
| Patents: | 0 |
Pharmacology for NDA: 040782
| Physiological Effect | Decreased Platelet Aggregation |
Medical Subject Heading (MeSH) Categories for 040782
Suppliers and Packaging for NDA: 040782
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIPYRIDAMOLE | dipyridamole | TABLET;ORAL | 040782 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1070 | 0115-1070-01 | 100 TABLET in 1 BOTTLE (0115-1070-01) |
| DIPYRIDAMOLE | dipyridamole | TABLET;ORAL | 040782 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1071 | 0115-1071-01 | 100 TABLET in 1 BOTTLE (0115-1071-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jul 18, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 18, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Jul 18, 2007 | TE: | AB | RLD: | No | ||||
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