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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078171
Company: CIPLA

Products on ANDA 078171

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION;INHALATION	Prescription	AN	No	No
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION;INHALATION	Prescription	AN	No	No
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078171

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2013	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
12/20/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/28/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/28/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078171

LEVALBUTEROL HYDROCHLORIDE

SOLUTION;INHALATION; EQ 0.0103% BASE
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION;INHALATION	Prescription	No	AN	078171	CIPLA
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION;INHALATION	Prescription	No	AN	077756	IMPAX LABS INC
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION;INHALATION	Prescription	No	AN	207625	LUOXIN AUROVITAS
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION;INHALATION	Prescription	No	AN	203653	RITEDOSE CORP
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION;INHALATION	Prescription	No	AN	090297	TEVA PHARMS USA

SOLUTION;INHALATION; EQ 0.021% BASE
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION;INHALATION	Prescription	No	AN	078171	CIPLA
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION;INHALATION	Prescription	No	AN	077756	IMPAX LABS INC
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION;INHALATION	Prescription	No	AN	207625	LUOXIN AUROVITAS
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION;INHALATION	Prescription	No	AN	215217	NEPHRON
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION;INHALATION	Prescription	No	AN	203653	RITEDOSE CORP
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION;INHALATION	Prescription	No	AN	090297	TEVA PHARMS USA

SOLUTION;INHALATION; EQ 0.042% BASE
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION;INHALATION	Prescription	No	AN	078171	CIPLA
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION;INHALATION	Prescription	No	AN	077756	IMPAX LABS INC
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION;INHALATION	Prescription	No	AN	207625	LUOXIN AUROVITAS
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION;INHALATION	Prescription	No	AN	215217	NEPHRON
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION;INHALATION	Prescription	No	AN	203653	RITEDOSE CORP
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION;INHALATION	Prescription	No	AN	090297	TEVA PHARMS USA

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