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Details for New Drug Application (NDA): 018679

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NDA 018679 describes TRIMETHOPRIM, which is a drug marketed by Novel Labs Inc, Watson Labs, Teva, Mayne Pharma, Sun Pharm Inds, Akorn Inc, Alcon Res Ltd, and Bausch And Lomb, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the TRIMETHOPRIM profile page.

The generic ingredient in TRIMETHOPRIM is polymyxin b sulfate; trimethoprim sulfate. There are ten drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.

Summary for NDA: 018679

Tradename:
TRIMETHOPRIM
Applicant:
Mayne Pharma
Ingredient:
trimethoprim
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 018679

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIMETHOPRIM
trimethoprim
TABLET;ORAL 018679 NDA Teva Pharmaceuticals USA, Inc. 0093-2158 0093-2158-01 100 TABLET in 1 BOTTLE (0093-2158-01)
TRIMETHOPRIM
trimethoprim
TABLET;ORAL 018679 NDA Mayne Pharma Inc. 51862-486 51862-486-01 100 TABLET in 1 BOTTLE (51862-486-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 30, 1982TE:ABRLD: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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