Details for New Drug Application (NDA): 075036
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The generic ingredient in CISPLATIN is cisplatin. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cisplatin profile page.
Summary for 075036
Tradename: | CISPLATIN |
Applicant: | Hikma |
Ingredient: | cisplatin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075036
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CISPLATIN | cisplatin | INJECTABLE;INJECTION | 075036 | ANDA | West-Ward Pharmaceuticals Corp | 0143-9504 | 0143-9504-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (0143-9504-01) / 50 mL in 1 VIAL, MULTI-DOSE |
CISPLATIN | cisplatin | INJECTABLE;INJECTION | 075036 | ANDA | West-Ward Pharmaceuticals Corp | 0143-9505 | 0143-9505-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (0143-9505-01) / 100 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
Approval Date: | Nov 7, 2000 | TE: | AP | RLD: | No |
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