Details for New Drug Application (NDA): 077030
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NDA 077030 describes CILOSTAZOL, which is a drug marketed by Actavis Elizabeth, Apotex Inc, Aurobindo Pharma Usa, Chartwell Rx, Epic Pharma Llc, Hikma, Ivax Sub Teva Pharms, Nostrum Labs Inc, Pliva Hrvatska Doo, Rising, Slate Run Pharma, and Teva, and is included in fourteen NDAs. It is available from nine suppliers. Additional details are available on the CILOSTAZOL profile page.
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.
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 Inc |
| 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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