Details for New Drug Application (NDA): 206774
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NDA 206774 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 206774
| Tradename: | CISPLATIN |
| Applicant: | Accord Hlthcare |
| Ingredient: | cisplatin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206774
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CISPLATIN | cisplatin | INJECTABLE;INJECTION | 206774 | ANDA | Accord Healthcare Inc. | 16729-288 | 16729-288-11 | 50 mL in 1 VIAL (16729-288-11) |
| CISPLATIN | cisplatin | INJECTABLE;INJECTION | 206774 | ANDA | Accord Healthcare Inc. | 16729-288 | 16729-288-38 | 100 mL in 1 VIAL (16729-288-38) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Aug 18, 2015 | TE: | AP | RLD: | No | ||||
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