Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 050608

Expand all

UNASYN (AMPICILLIN SODIUM; SULBACTAM SODIUM)
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: AMPICILLIN SODIUM; SULBACTAM SODIUM
Proprietary Name: UNASYN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N050608
Product Number: 002
Approval Date: Dec 31, 1986
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

UNASYN (AMPICILLIN SODIUM; SULBACTAM SODIUM)
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: AMPICILLIN SODIUM; SULBACTAM SODIUM
Proprietary Name: UNASYN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N050608
Product Number: 001
Approval Date: Dec 31, 1986
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

UNASYN (AMPICILLIN SODIUM; SULBACTAM SODIUM)
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: AMPICILLIN SODIUM; SULBACTAM SODIUM
Proprietary Name: UNASYN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N050608
Product Number: 005
Approval Date: Dec 10, 1993
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

UNASYN (AMPICILLIN SODIUM; SULBACTAM SODIUM)
EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL
Marketing Status: Discontinued

Active Ingredient: AMPICILLIN SODIUM; SULBACTAM SODIUM
Proprietary Name: UNASYN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050608
Product Number: 003
Approval Date: Dec 31, 1986
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information