Details for New Drug Application (NDA): 214238
✉ Email this page to a colleague
NDA 214238 describes PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Hikma, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, and Wockhardt Bio Ag, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE profile page.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.
Summary for 214238
| Tradename: | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
| Applicant: | Quagen |
| Ingredient: | codeine phosphate; promethazine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 214238
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 214238
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | codeine phosphate; promethazine hydrochloride | SYRUP;ORAL | 214238 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-139 | 70752-139-06 | 118 mL in 1 BOTTLE, PLASTIC (70752-139-06) |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | codeine phosphate; promethazine hydrochloride | SYRUP;ORAL | 214238 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-139 | 70752-139-12 | 473 mL in 1 BOTTLE, PLASTIC (70752-139-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML;6.25MG/5ML | ||||
| Approval Date: | Oct 8, 2020 | TE: | AA | RLD: | No | ||||
Complete Access Available with Subscription
