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): 203835
Company: HETERO LABS LTD V

Products on ANDA 203835

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	AB	No	No
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	AB	No	No
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203835

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203835Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2025	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
07/14/2022	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/04/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/10/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203835

LOSARTAN POTASSIUM

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COZAAR	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	Yes	AB	020386	ORGANON
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	090544	AIPING PHARM INC
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	090428	ALEMBIC PHARMS LTD
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	090083	AUROBINDO PHARMA
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	077424	CHARTWELL RX
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	215959	GRANULES
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	219859	GRAVITI PHARMS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	203835	HETERO LABS LTD V
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	201170	JUBILANT CADISTA
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	078232	LUPIN LTD
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	202230	MACLEODS PHARMS LTD
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	091541	MICRO LABS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	217396	MSN
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	091497	PRINSTON INC
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	090382	STRIDES PHARMA
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	203030	UNICHEM
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	091129	WATSON LABS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	078243	ZYDUS PHARMS USA INC

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COZAAR	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	Yes	AB	020386	ORGANON
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	090544	AIPING PHARM INC
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	090428	ALEMBIC PHARMS LTD
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	090083	AUROBINDO PHARMA
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	077424	CHARTWELL RX
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	215959	GRANULES
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	219859	GRAVITI PHARMS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	203835	HETERO LABS LTD V
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	201170	JUBILANT CADISTA
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	078232	LUPIN LTD
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	202230	MACLEODS PHARMS LTD
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	091541	MICRO LABS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	217396	MSN
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	091497	PRINSTON INC
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	090382	STRIDES PHARMA
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	203030	UNICHEM
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	091129	WATSON LABS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	078243	ZYDUS PHARMS USA INC

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COZAAR	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	Yes	AB	020386	ORGANON
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	090544	AIPING PHARM INC
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	090428	ALEMBIC PHARMS LTD
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	090083	AUROBINDO PHARMA
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	077424	CHARTWELL RX
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	215959	GRANULES
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	219859	GRAVITI PHARMS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	203835	HETERO LABS LTD V
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	201170	JUBILANT CADISTA
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	078232	LUPIN LTD
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	202230	MACLEODS PHARMS LTD
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	091541	MICRO LABS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	217396	MSN
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	091497	PRINSTON INC
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	090382	STRIDES PHARMA
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	203030	UNICHEM
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	091129	WATSON LABS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	078243	ZYDUS PHARMS USA INC

Top