Details for New Drug Application (NDA): 040654
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The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 040654
Tradename: | PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE |
Applicant: | Genus |
Ingredient: | phenylephrine hydrochloride; promethazine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 040654
Mechanism of Action | Adrenergic alpha1-Agonists |
Suppliers and Packaging for NDA: 040654
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE | phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040654 | ANDA | PAI Holdings, LLC | 0121-0926 | 0121-0926-16 | 437 mL in 1 BOTTLE (0121-0926-16) |
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE | phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040654 | ANDA | Genus Lifesciences Inc. | 64950-345 | 64950-345-16 | 473 mL in 1 BOTTLE, PLASTIC (64950-345-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML;6.25MG/5ML | ||||
Approval Date: | Dec 7, 2006 | TE: | AA | RLD: | No |
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