Details for New Drug Application (NDA): 040902
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NDA 040902 describes PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE profile page.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE 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.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE 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 040902
| Tradename: | PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE |
| Applicant: | Amneal Pharms |
| Ingredient: | phenylephrine hydrochloride; promethazine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 040902
| Mechanism of Action | Adrenergic alpha1-Agonists |
Suppliers and Packaging for NDA: 040902
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040902 | ANDA | Amneal Pharmaceuticals LLC | 65162-679 | 65162-679-86 | 118 mL in 1 BOTTLE (65162-679-86) |
| PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040902 | ANDA | Amneal Pharmaceuticals LLC | 65162-679 | 65162-679-90 | 473 mL in 1 BOTTLE (65162-679-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML;6.25MG/5ML | ||||
| Approval Date: | Aug 25, 2009 | TE: | AA | RLD: | No | ||||
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