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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200894

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NDA 200894 describes PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Hi Tech Pharma, Nostrum Labs Inc, Pharm Assoc, Tris Pharma Inc, and Wockhardt, and is included in seven NDAs. It is available from thirteen 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. Twenty suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.

Summary for 200894

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 200894

Ingredient-typePhenothiazines
Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 200894

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 200894 ANDA Amneal Pharmaceuticals LLC 65162-695 65162-695-90 473 mL in 1 BOTTLE (65162-695-90)
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 200894 ANDA Amneal Pharmaceuticals LLC 65162-695 65162-695-86 118 mL in 1 BOTTLE (65162-695-86)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength10MG/5ML;6.25MG/5ML
Approval Date:Apr 24, 2013TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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US Army
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McKinsey
Argus Health
Federal Trade Commission
Farmers Insurance
Chubb

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