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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077788
Company: CHARTWELL RX

Products on ANDA 077788

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077788

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2007	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 077788

ALBUTEROL SULFATE

SYRUP;ORAL; EQ 2MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP;ORAL	Prescription	No	AA	079241	AMNEAL PHARMS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP;ORAL	Prescription	No	AA	078105	CHARTWELL MOLECULAR
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP;ORAL	Prescription	No	AA	077788	CHARTWELL RX
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP;ORAL	Prescription	No	AA	074454	COSETTE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP;ORAL	Prescription	No	AA	212197	QUAGEN
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP;ORAL	Prescription	No	AA	073419	TEVA

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