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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207290
Company: MACLEODS PHARMS LTD

Products on ANDA 207290

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207290

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2019	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
02/11/2021	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207290

TADALAFIL

TABLET;ORAL; 20MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADCIRCA	TADALAFIL	20MG	TABLET;ORAL	Prescription	Yes	AB2	022332	ELI LILLY CO
ALYQ	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	216932	TEVA PHARMS INC
ALYQ	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	209942	TEVA PHARMS USA
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	210392	AJANTA PHARMA LTD
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	206286	AUROBINDO PHARMA LTD
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	210255	CIPLA
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	210145	DR REDDYS
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	209907	HETERO LABS LTD III
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	210572	LUPIN LTD
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	207290	MACLEODS PHARMS LTD
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	210608	PRINSTON INC
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	213496	SUNSHINE
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	212062	TORRENT

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