Details for New Drug Application (NDA): 040649
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NDA 040649 describes PROMETHAZINE DM, which is a drug marketed by Slate Run Pharma and is included in one NDA. It is available from seven 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-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
The generic ingredient in PROMETHAZINE DM is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Twelve 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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