An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090229
Company: SYNTHON PHARMS

Products on ANDA 090229

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090229

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090229s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2021	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
03/18/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/07/2017	SUPPL-16	Labeling-Container/Carton Labels		Label is not available on this site.
06/29/2015	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/29/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/29/2015	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/30/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/27/2011	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 090229

LEVOCETIRIZINE DIHYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090392	DR REDDYS LABS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090385	GLENMARK PHARMS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	091264	HETERO LABS LTD III
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	205564	MACLEODS PHARMS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	202046	MICRO LABS LTD INDIA
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	203646	SCIEGEN PHARMS INC
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090362	SUN PHARM
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090229	SYNTHON PHARMS
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090199	TEVA PHARMS

Top