Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018057

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CISPLATIN (CISPLATIN)
1MG/ML
Marketing Status: Prescription

Active Ingredient: CISPLATIN
Proprietary Name: CISPLATIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N018057
Product Number: 004
Approval Date: Nov 8, 1988
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

CISPLATIN (CISPLATIN)
50MG/VIAL
Marketing Status: Prescription

Active Ingredient: CISPLATIN
Proprietary Name: CISPLATIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018057
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

PLATINOL (CISPLATIN)
10MG/VIAL
Marketing Status: Discontinued

Active Ingredient: CISPLATIN
Proprietary Name: PLATINOL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018057
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

PLATINOL-AQ (CISPLATIN)
0.5MG/ML
Marketing Status: Discontinued

Active Ingredient: CISPLATIN
Proprietary Name: PLATINOL-AQ
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018057
Product Number: 003
Approval Date: Jul 18, 1984
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information