Orange Book product · Brand (NDA)
LONITEN
MINOXIDIL
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MINOXIDIL
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018154
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2006MEN'S ROGAINEBrand (NDA)
NDA 021812 · KENVUE BRANDS
- 1997ROGAINE EXTRA STRENGTH (FOR MEN)Brand (NDA)
NDA 020834 · KENVUE BRANDS
- 1996ROGAINE (FOR MEN)Brand (NDA)
NDA 019501 · KENVUE BRANDS
- 2025MINOXIDIL EXTRA STRENGTH (FOR MEN)Generic (ANDA)
ANDA 217998 · TARO
- 2024MINOXIDIL (FOR WOMEN)Generic (ANDA)
ANDA 218175 · TARO
- 2024MINOXIDIL (FOR MEN)Generic (ANDA)
ANDA 218616 · AUROBINDO PHARMA
- 2018MINOXIDIL (FOR MEN)Generic (ANDA)
ANDA 209074 · TARO
- 2017MINOXIDIL (FOR MEN)Generic (ANDA)
ANDA 208092 · P AND L
- 2011MINOXIDILGeneric (ANDA)
ANDA 091344 · PERRIGO PHARMA INTL
- 2007THEROXIDILGeneric (ANDA)
ANDA 078176 · PURE SOURCE
- 2004THEROXIDILGeneric (ANDA)
ANDA 076239 · PURE SOURCE
- 2003MINOXIDIL EXTRA STRENGTH (FOR MEN)Generic (ANDA)
ANDA 075438 · AUROBINDO PHARMA LTD
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.
