Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050748

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SYNERCID (DALFOPRISTIN; QUINUPRISTIN)
350MG/VIAL;150MG/VIAL
Marketing Status: Prescription

Active Ingredient: DALFOPRISTIN; QUINUPRISTIN
Proprietary Name: SYNERCID
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 350MG/VIAL;150MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050748
Product Number: 001
Approval Date: Sep 21, 1999
Applicant Holder Full Name: KING PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SYNERCID (DALFOPRISTIN; QUINUPRISTIN)
420MG/VIAL;180MG/VIAL
Marketing Status: Discontinued

Active Ingredient: DALFOPRISTIN; QUINUPRISTIN
Proprietary Name: SYNERCID
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 420MG/VIAL;180MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050748
Product Number: 002
Approval Date: Aug 24, 2000
Applicant Holder Full Name: KING PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information