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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Argus Health
US Department of Justice
Farmers Insurance
QuintilesIMS
Dow
Covington
Fish and Richardson
Julphar

Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040649

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NDA 040649 describes PROMETHAZINE DM, which is a drug marketed by Vintage and is included in one NDA. It is available from eight suppliers. Additional details are available on the PROMETHAZINE DM profile page.

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

Summary for NDA: 040649

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

Pharmacology for NDA: 040649

Suppliers and Packaging for NDA: 040649

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE DM
dextromethorphan hydrobromide; promethazine hydrochloride
SYRUP;ORAL 040649 ANDA Par Pharmaceutical 0603-1586 0603-1586-54 118 mL in 1 BOTTLE (0603-1586-54)
PROMETHAZINE DM
dextromethorphan hydrobromide; promethazine hydrochloride
SYRUP;ORAL 040649 ANDA Par Pharmaceutical 0603-1586 0603-1586-58 473 mL in 1 BOTTLE (0603-1586-58)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML;6.25MG/5ML
Approval Date:Feb 14, 2006TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
AstraZeneca
Baxter
Accenture
UBS
US Department of Justice
Daiichi Sankyo
Mallinckrodt
Julphar
QuintilesIMS

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