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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091263
Company: PADAGIS US

Products on ANDA 091263

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091263

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2011	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091263s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2025	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
07/10/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/10/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/10/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/10/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/10/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/10/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/15/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/27/2014	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 091263

LEVOCETIRIZINE DIHYDROCHLORIDE

SOLUTION;ORAL; 2.5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204599	CHARTWELL MOLECULAR
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	091263	PADAGIS US
LEVOCETIRIZINE HYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210914	HETERO LABS LTD III

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