Details for New Drug Application (NDA): 213890
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The generic ingredient in PROMETHAZINE HYDROCHLORIDE 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 213890
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Quagen |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213890
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SYRUP;ORAL | 213890 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-138 | 70752-138-06 | 118 mL in 1 BOTTLE, PLASTIC (70752-138-06) |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SYRUP;ORAL | 213890 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-138 | 70752-138-12 | 473 mL in 1 BOTTLE, PLASTIC (70752-138-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 6.25MG/5ML | ||||
Approval Date: | Jul 12, 2021 | TE: | AA | RLD: | No |
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