Orange Book product · Generic (ANDA)
TADALAFIL
TADALAFIL
At a glance
Mar 26, 2019
Approved
Generic (ANDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 26, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
TADALAFIL
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB1
Application
ANDA 206285
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TADALAFIL
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- 2008CIALISBrand (NDA)
NDA 021368 · LILLY
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ANDA 210329 · JUBILANT GENERICS
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ANDA 217606 · FOURRTS LABS
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ANDA 215949 · NOVITIUM PHARMA
- 2022ALYQGeneric (ANDA)
ANDA 216932 · TEVA PHARMS INC
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ANDA 210609 · PRINSTON INC
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ANDA 210608 · PRINSTON INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
