Details for New Drug Application (NDA): 040649
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The generic ingredient in PROMETHAZINE DM is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
Summary for 040649
Tradename: | PROMETHAZINE DM |
Applicant: | Slate Run Pharma |
Ingredient: | dextromethorphan hydrobromide; promethazine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 040649
Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
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 | ATLANTIC BIOLOGICALS CORP. | 17856-0155 | 17856-0155-1 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0155-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0155-2) |
PROMETHAZINE DM | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 040649 | ANDA | A-S Medication Solutions | 50090-6585 | 50090-6585-0 | 118 mL in 1 BOTTLE (50090-6585-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 15MG/5ML;6.25MG/5ML | ||||
Approval Date: | Feb 14, 2006 | TE: | AA | RLD: | No |
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