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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205564
Company: MACLEODS PHARMS LTD

Products on ANDA 205564

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 205564

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2026	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
07/11/2025	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
09/13/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/13/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/13/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/18/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/18/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/18/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205564

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
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 BV
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090199	TEVA PHARMS

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