Orange Book product · Brand (NDA)
ARESTIN
MINOCYCLINE HYDROCHLORIDE
At a glance
Feb 16, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 16, 2001
25 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
MINOCYCLINE HYDROCHLORIDE
Strength
EQ 1MG BASE
Dosage form
POWDER, EXTENDED RELEASE
Route
DENTAL
TE code
Not listed
Application
NDA 050781
Product number
001
Marketing status
RX
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.
- 2024EMROSIBrand (NDA)
NDA 219015 · JOURNEY
- 2020ZILXIBrand (NDA)
NDA 213690 · JOURNEY
- 2019AMZEEQBrand (NDA)
NDA 212379 · JOURNEY
- 2017MINOLIRABrand (NDA)
NDA 209269 · EPI HLTH
- 2012XIMINOBrand (NDA)
NDA 201922 · JOURNEY
- 2006SOLODYNBrand (NDA)
NDA 050808 · BAUSCH
- 1990MINOCINBrand (NDA)
NDA 050649 · BAUSCH
- 1982MINOCYCLINE HYDROCHLORIDEBrand (NDA)
NDA 050451 · TRIAX PHARMS
- —MINOCINBrand (NDA)
NDA 050315 · TRIAX PHARMS
- —MINOCINBrand (NDA)
NDA 050444 · REMPEX
- —MINOCINBrand (NDA)
NDA 050445 · BAUSCH
- 2022MINOCYCLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215466 · REGCON HOLDINGS
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.
