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, 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 040733
| Tradename: | DIPYRIDAMOLE |
| Applicant: | Rising |
| Ingredient: | dipyridamole |
| Patents: | 0 |
Pharmacology for NDA: 040733
| Physiological Effect | Decreased 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 | Proficient Rx LP | 71205-894 | 71205-894-00 | 100 TABLET, FILM COATED in 1 BOTTLE (71205-894-00) |
| DIPYRIDAMOLE | dipyridamole | TABLET;ORAL | 040733 | ANDA | Proficient Rx LP | 71205-894 | 71205-894-11 | 1000 TABLET, FILM COATED in 1 BOTTLE (71205-894-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 13, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 13, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Feb 13, 2007 | TE: | AB | RLD: | No | ||||
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