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Details for New Drug Application (NDA): 074973

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NDA 074973 describes PRIMSOL, which is a drug marketed by Aytu Bioscience Inc and Aytu Pharms and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the PRIMSOL profile page.

The generic ingredient in PRIMSOL is trimethoprim hydrochloride. There are thirty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the trimethoprim hydrochloride profile page.

Summary for NDA: 074973

Tradename:
PRIMSOL
Applicant:
Aytu Bioscience Inc
Ingredient:
trimethoprim hydrochloride
Patents:2
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 074973

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMSOL
trimethoprim hydrochloride
SOLUTION;ORAL 074973 NDA FSC Laboratories, Inc 13551-501 13551-501-01 20 mL in 1 BOTTLE, PLASTIC (13551-501-01)
PRIMSOL
trimethoprim hydrochloride
SOLUTION;ORAL 074973 NDA FSC Laboratories, Inc 13551-501 13551-501-05 473 mL in 1 BOTTLE, PLASTIC (13551-501-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 50MG BASE/5ML
Approval Date:Jan 24, 2000TE:RLD:Yes
Patent:5,763,449Patent Expiration:Aug 7, 2016Product Flag?Substance Flag?Delist Request?
Patent:5,962,461Patent Expiration:Aug 7, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 074973

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aytu Bioscience Inc
PRIMSOL
trimethoprim hydrochloride
SOLUTION;ORAL074973-001Jan 24, 20005,763,449► subscribe
Aytu Bioscience Inc
PRIMSOL
trimethoprim hydrochloride
SOLUTION;ORAL074973-001Jan 24, 20005,962,461► subscribe
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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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