Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200875
Company: TEVA PARENTERAL

Products on ANDA 200875

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200875

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/2014	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2020	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/11/2016	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
11/17/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/17/2015	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200875

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