Orange Book product · Brand (NDA)
ROGAINE EXTRA STRENGTH (FOR MEN)
MINOXIDIL
At a glance
Nov 14, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 1997
29 yr ago
Today
Pharmaceutical detail
Active ingredient
MINOXIDIL
Strength
5%
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 020834
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 1996ROGAINE (FOR MEN)Brand (NDA)
NDA 019501 · KENVUE BRANDS
- —LONITENBrand (NDA)
NDA 018154 · PFIZER
- 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.
