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Details for New Drug Application (NDA): 062527

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NDA 062527 describes NAFCILLIN SODIUM, which is a drug marketed by Istituto Bio Ita Spa, Mylan Labs Ltd, Watson Labs Inc, Aurobindo Pharma Ltd, Sandoz, Antibiotice, Sagent Pharms, and Apothecon, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the NAFCILLIN SODIUM profile page.

The generic ingredient in NAFCILLIN SODIUM is nafcillin sodium. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.

Summary for NDA: 062527

Tradename:
NAFCILLIN SODIUM
Applicant:
Sandoz
Ingredient:
nafcillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 062527

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 062527

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFCILLIN SODIUM
nafcillin sodium
INJECTABLE;INJECTION 062527 ANDA Sandoz Inc 0781-3124 0781-3124-95 10 VIAL in 1 PACKAGE (0781-3124-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3124-85)
NAFCILLIN SODIUM
nafcillin sodium
INJECTABLE;INJECTION 062527 ANDA Sandoz Inc 0781-3125 0781-3125-95 10 VIAL in 1 PACKAGE (0781-3125-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3125-85)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Aug 2, 1984TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Aug 2, 1984TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Aug 2, 1984TE:APRLD:Yes


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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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