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Details for New Drug Application (NDA): 050608

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NDA 050608 describes UNASYN, which is a drug marketed by Pfizer and is included in two NDAs. It is available from one supplier. Additional details are available on the UNASYN profile page.

The generic ingredient in UNASYN is ampicillin sodium; sulbactam sodium. There are sixty-nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.

Summary for NDA: 050608

Tradename:
UNASYN
Applicant:
Pfizer
Ingredient:
ampicillin sodium; sulbactam sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050608

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 050608

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UNASYN
ampicillin sodium; sulbactam sodium
INJECTABLE;INJECTION 050608 NDA Roerig 0049-0013 0049-0013-83 10 VIAL in 1 CARTON (0049-0013-83) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0013-81)
UNASYN
ampicillin sodium; sulbactam sodium
INJECTABLE;INJECTION 050608 NDA Roerig 0049-0014 0049-0014-83 10 VIAL in 1 CARTON (0049-0014-83) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:Dec 31, 1986TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Dec 31, 1986TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date:Dec 31, 1986TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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