FDA.report

Tadalafil

Product NDC
16714-075
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA208934
Marketing category
ANDA
Substance
TADALAFIL
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
16714-075-0130 TABLET, FILM COATED in 1 BOTTLE (16714-075-01) 2020-02-19NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003A-S Medication Solutions2024-10-24Human Prescription Drug Label2
These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003A-S Medication Solutions2024-10-24Human Prescription Drug Label1
These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003NorthStar RxLLC | Sun Pharmaceutical Industries Limited2023-11-10Human Prescription Drug Label2
These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2023-03-22HUMAN PRESCRIPTION DRUG LABEL2