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Details for New Drug Application (NDA): 018057

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NDA 018057 describes PLATINOL-AQ, which is a drug marketed by Hq Spclt Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the PLATINOL-AQ profile page.

The generic ingredient in PLATINOL-AQ is cisplatin. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cisplatin profile page.

Summary for NDA: 018057

Tradename:
CISPLATIN
Applicant:
Hq Spclt Pharma
Ingredient:
cisplatin
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 018057

Suppliers and Packaging for NDA: 018057

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CISPLATIN
cisplatin
INJECTABLE;INJECTION 018057 NDA WG Critical Care, LLC 44567-509 44567-509-01 1 VIAL, MULTI-DOSE in 1 CARTON (44567-509-01) > 50 mL in 1 VIAL, MULTI-DOSE
CISPLATIN
cisplatin
INJECTABLE;INJECTION 018057 NDA WG Critical Care, LLC 44567-510 44567-510-01 1 VIAL, MULTI-DOSE in 1 CARTON (44567-510-01) > 100 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.5MG/ML
Approval Date:Jul 18, 1984TE:RLD:No

Expired Orange Book Patents for NDA: 018057

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hq Spclt Pharma
CISPLATIN
cisplatin
INJECTABLE;INJECTION018057-004Nov 8, 19884,177,263► subscribe
Hq Spclt Pharma
PLATINOL
cisplatin
INJECTABLE;INJECTION018057-001Approved Prior to Jan 1, 19825,562,925► subscribe
Hq Spclt Pharma
PLATINOL-AQ
cisplatin
INJECTABLE;INJECTION018057-003Jul 18, 19845,562,925► subscribe
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