Details for New Drug Application (NDA): 090180

NDA 090180 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.

Summary for 090180

Tradename:	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Applicant:	Nostrum Labs Inc
Ingredient:	codeine phosphate; promethazine hydrochloride
Patents:	0

Pharmacology for NDA: 090180

Mechanism of Action

Full Opioid Agonists

Suppliers and Packaging for NDA: 090180

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	090180	ANDA	Nostrum Laboratories, Inc.	70408-185	70408-185-31	118 mL in 1 BOTTLE (70408-185-31)
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	090180	ANDA	Nostrum Laboratories, Inc.	70408-185	70408-185-34	473 mL in 1 BOTTLE (70408-185-34)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	10MG/5ML;6.25MG/5ML
Approval Date:	Mar 17, 2010	TE:	AA	RLD:	No

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