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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 nine 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. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.

Summary for NDA: 040649

Tradename:
PROMETHAZINE DM
Applicant:
Vintage
Ingredient:
dextromethorphan hydrobromide; promethazine hydrochloride
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 Qualitest Pharmaceuticals 0603-1586 0603-1586-54 118 mL in 1 BOTTLE (0603-1586-54)
PROMETHAZINE DM
dextromethorphan hydrobromide; promethazine hydrochloride
SYRUP;ORAL 040649 ANDA Qualitest Pharmaceuticals 0603-1586 0603-1586-56 237 mL in 1 BOTTLE (0603-1586-56)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML;6.25MG/5ML
Approval Date:Feb 14, 2006TE:AARLD:Yes


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