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Details for New Drug Application (NDA): 050748

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NDA 050748 describes SYNERCID, which is a drug marketed by King Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the SYNERCID profile page.

The generic ingredient in SYNERCID is dalfopristin; quinupristin. One supplier is listed for this compound. Additional details are available on the dalfopristin; quinupristin profile page.

Summary for NDA: 050748

Formulation / Manufacturing:see details

Pharmacology for NDA: 050748


Suppliers and Packaging for NDA: 050748

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dalfopristin; quinupristin
INJECTABLE;IV (INFUSION) 050748 NDA Pfizer Laboratories Div Pfizer Inc 61570-260 61570-260-10 10 VIAL, GLASS in 1 CARTON (61570-260-10) > 5 mL in 1 VIAL, GLASS (61570-260-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength350MG/VIAL;150MG/VIAL
Approval Date:Sep 21, 1999TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;IV (INFUSION)Strength420MG/VIAL;180MG/VIAL
Approval Date:Aug 24, 2000TE:RLD:No

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