Details for New Drug Application (NDA): 077030
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The generic ingredient in CILOSTAZOL is cilostazol. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cilostazol profile page.
Summary for 077030
| Tradename: | CILOSTAZOL |
| Applicant: | Apotex |
| Ingredient: | cilostazol |
| Patents: | 0 |
Pharmacology for NDA: 077030
| Mechanism of Action | Phosphodiesterase 3 Inhibitors |
Suppliers and Packaging for NDA: 077030
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CILOSTAZOL | cilostazol | TABLET;ORAL | 077030 | ANDA | AvKARE | 42291-453 | 42291-453-60 | 60 TABLET in 1 BOTTLE (42291-453-60) |
| CILOSTAZOL | cilostazol | TABLET;ORAL | 077030 | ANDA | AvPAK | 50268-176 | 50268-176-15 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-176-15) / 1 TABLET in 1 BLISTER PACK (50268-176-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 10, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 10, 2004 | TE: | AB | RLD: | No | ||||
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