Last Updated: August 8, 2026

Details for New Drug Application (NDA): 207244

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NDA 207244 describes TADALAFIL, which is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Fourrts Labs, Hangzhou Binjiang, Hetero Labs Ltd Iii, Jubilant Generics, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Novitium Pharma, Pharmobedient, Prinston Inc, Qilu Pharm Hainan, Rising, Shandong, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Umedica, Unichem, Vkt Pharma, Watson Labs Inc, and Zydus Pharms, and is included in forty-one NDAs. It is available from forty-eight suppliers. Additional details are available on the TADALAFIL profile page.

The generic ingredient in TADALAFIL is tadalafil. There are twenty-five drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the tadalafil profile page.

Summary for 207244

Tradename:	TADALAFIL
Applicant:	Macleods Pharms Ltd
Ingredient:	tadalafil
Patents:	0

Pharmacology for NDA: 207244

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for 207244

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 207244

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TADALAFIL	tadalafil	TABLET;ORAL	207244	ANDA	Macleods Pharmaceuticals Limited	33342-265	33342-265-07	30 TABLET, FILM COATED in 1 BOTTLE (33342-265-07)
TADALAFIL	tadalafil	TABLET;ORAL	207244	ANDA	Macleods Pharmaceuticals Limited	33342-265	33342-265-44	1000 TABLET, FILM COATED in 1 BOTTLE (33342-265-44)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Oct 7, 2019	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 7, 2019	TE:	AB1	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 7, 2019	TE:	AB1	RLD:	No

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