Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040643
Company: PHARM ASSOC

• Other Important Information from FDA

Products on ANDA 040643

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040643

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2006	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2006	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040643

PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL; 6.25MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040026	CHARTWELL RX
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	091675	COSETTE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040643	PHARM ASSOC
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	213890	QUAGEN
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040891	STRIDES PHARMA
PROMETHAZINE PLAIN	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	087953	PHARMOBEDIENT