Orange Book product · Brand (NDA)
SOLODYN
MINOCYCLINE HYDROCHLORIDE
At a glance
May 08, 2006
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 08, 2006
20 yr 5 mo ago
Today
Patent 7919483 expires
Listed method-of-use patent (U-1078) expiration.
Mar 07, 2027
in 9 mo
Pharmaceutical detail
Active ingredient
MINOCYCLINE HYDROCHLORIDE
Strength
EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 050808
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.
- 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
- 2001ARESTINBrand (NDA)
NDA 050781 · ORAPHARMA
- 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 (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7919483 | Mar 07, 2027 | in 9 mo | U-1078 |
