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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203030
Company: UNICHEM

Products on ANDA 203030

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 203030

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/14/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203030Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2022	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/07/2019	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/10/2016	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203030

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	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	203835	HETERO LABS LTD V
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	No	AB	200290	IPCA LABS LTD
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	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	203835	HETERO LABS LTD V
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	No	AB	200290	IPCA LABS LTD
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	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	203835	HETERO LABS LTD V
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	No	AB	200290	IPCA LABS LTD
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

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