Details for New Drug Application (NDA): 040654
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NDA 040654 describes PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Genus and Hikma and is included in two NDAs. It is available from two suppliers. Additional details are available on the PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE profile page.
The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE 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 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE 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 040654
| Tradename: | PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE |
| Applicant: | Genus |
| Ingredient: | phenylephrine hydrochloride; promethazine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 040654
| Mechanism of Action | Adrenergic alpha1-Agonists |
Suppliers and Packaging for NDA: 040654
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE | phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040654 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0926 | 0121-0926-16 | 437 mL in 1 BOTTLE (0121-0926-16) |
| PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE | phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040654 | ANDA | Genus Lifesciences Inc. | 64950-345 | 64950-345-16 | 473 mL in 1 BOTTLE, PLASTIC (64950-345-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML;6.25MG/5ML | ||||
| Approval Date: | Dec 7, 2006 | TE: | AA | RLD: | No | ||||
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