Details for New Drug Application (NDA): 200963
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NDA 200963 describes PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, 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,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE profile page.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE 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.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE 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 200963
| Tradename: | PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE |
| Applicant: | Amneal Pharms |
| Ingredient: | codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 200963
| Mechanism of Action | Adrenergic alpha1-Agonists Full Opioid Agonists |
Suppliers and Packaging for NDA: 200963
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE | codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 200963 | ANDA | Amneal Pharmaceuticals LLC | 65162-694 | 65162-694-86 | 118 mL in 1 BOTTLE (65162-694-86) |
| PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE | codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 200963 | ANDA | Amneal Pharmaceuticals LLC | 65162-694 | 65162-694-90 | 473 mL in 1 BOTTLE (65162-694-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML;5MG/5ML;6.25MG/5ML | ||||
| Approval Date: | Aug 26, 2015 | TE: | AA | RLD: | No | ||||
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