Details for New Drug Application (NDA): 040882
✉ Email this page to a colleague
The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 040882
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Amneal Pharms |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 040882
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SYRUP;ORAL | 040882 | ANDA | Amneal Pharmaceuticals LLC | 65162-678 | 65162-678-86 | 118 mL in 1 BOTTLE (65162-678-86) |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SYRUP;ORAL | 040882 | ANDA | Amneal Pharmaceuticals LLC | 65162-678 | 65162-678-90 | 473 mL in 1 BOTTLE (65162-678-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 6.25MG/5ML | ||||
Approval Date: | Dec 30, 2009 | TE: | RLD: | No |
Complete Access Available with Subscription