Details for New Drug Application (NDA): 074735
✉ Email this page to a colleague
NDA 074735 describes CISPLATIN, which is a drug marketed by Accord Hlthcare, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, Norvium Bioscience, Pharmachemie Bv, Qilu, and Teva Pharms Usa, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the CISPLATIN profile page.
The generic ingredient in CISPLATIN is cisplatin. There are fourteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cisplatin profile page.
The generic ingredient in CISPLATIN is cisplatin. There are fourteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cisplatin profile page.
Summary for 074735
| Tradename: | CISPLATIN |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | cisplatin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 074735
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CISPLATIN | cisplatin | INJECTABLE;INJECTION | 074735 | ANDA | Fresenius Kabi USA, LLC | 63323-103 | 63323-103-51 | 1 VIAL in 1 CARTON (63323-103-51) / 50 mL in 1 VIAL |
| CISPLATIN | cisplatin | INJECTABLE;INJECTION | 074735 | ANDA | Fresenius Kabi USA, LLC | 63323-103 | 63323-103-64 | 1 VIAL in 1 CARTON (63323-103-64) / 200 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Jul 16, 1999 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
