Details for New Drug Application (NDA): 040674
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The generic ingredient in PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 040674
Tradename: | PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE |
Applicant: | Hikma |
Ingredient: | codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 040674
Mechanism of Action | Adrenergic alpha1-Agonists Full Opioid Agonists |
Suppliers and Packaging for NDA: 040674
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE | codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040674 | ANDA | Akorn | 50383-805 | 50383-805-04 | 118 mL in 1 BOTTLE (50383-805-04) |
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE | codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040674 | ANDA | Akorn | 50383-805 | 50383-805-16 | 473 mL in 1 BOTTLE (50383-805-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML;5MG/5ML;6.25MG/5ML | ||||
Approval Date: | Dec 23, 2014 | TE: | AA | RLD: | No |
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