Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078309
Company: MYLAN SPECIALITY LP

Products on ANDA 078309

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION;INHALATION	Prescription	AN	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078309

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/20/2009	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
04/12/2023	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/25/2017	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/25/2017	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/10/2013	SUPPL-9	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
02/19/2013	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078309

LEVALBUTEROL HYDROCHLORIDE

SOLUTION;INHALATION; EQ 0.25% 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 0.25% BASE	SOLUTION;INHALATION	Prescription	No	AN	207628	LUOXIN AUROVITAS
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION;INHALATION	Prescription	No	AN	078309	MYLAN SPECIALITY LP
LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION;INHALATION	Prescription	No	AN	200875	TEVA PARENTERAL