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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090575

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NDA 090575 describes PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Hi Tech Pharma, and Tris Pharma Inc, and is included in four NDAs. It is available from two suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.

Summary for 090575

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090575

Suppliers and Packaging for NDA: 090575

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 090575 ANDA Amneal Pharmaceuticals 65162-680 65162-680-90 473 mL in 1 BOTTLE (65162-680-90)
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 090575 ANDA Amneal Pharmaceuticals 65162-680 65162-680-86 118 mL in 1 BOTTLE (65162-680-86)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength15MG/5ML;6.25MG/5ML
Approval Date:Feb 8, 2011TE: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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