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Details for New Drug Application (NDA): 050624

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NDA 050624 describes ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Hoffmann La Roche and is included in one NDA. Additional details are available on the ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER profile page.

The generic ingredient in ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER is ceftriaxone sodium. There are twenty-three drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.

Summary for NDA: 050624

Tradename:
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
Applicant:
Hoffmann La Roche
Ingredient:
ceftriaxone sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Feb 11, 1987TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/ML
Approval Date:Feb 11, 1987TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Feb 11, 1987TE: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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