Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040654
Company: PAI HOLDINGS

• Other Important Information from FDA

Products on ANDA 040654

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040654

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/2006	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 040654

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040654	PAI HOLDINGS
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040902	AMNEAL PHARMS