Orange Book product · Brand (NDA)
TIGECYCLINE
TIGECYCLINE
At a glance
Dec 01, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 01, 2016
9 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
TIGECYCLINE
Strength
50MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 205645
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.
- 2018TIGECYCLINEBrand (NDA)
NDA 211158 · AMNEAL
- 2018TIGECYCLINEBrand (NDA)
NDA 208744 · ACCORD HLTHCARE INC
- 2005TYGACILBrand (NDA)
NDA 021821 · PF PRISM CV
- 2021TIGECYCLINEGeneric (ANDA)
ANDA 214020 · MEITHEAL
- 2019TIGECYCLINEGeneric (ANDA)
ANDA 205722 · XELLIA PHARMS APS
- 2019TIGECYCLINEGeneric (ANDA)
ANDA 206335 · EUGIA PHARMA
- 2018TIGECYCLINEGeneric (ANDA)
ANDA 204439 · APOTEX
- 2015TIGECYCLINEGeneric (ANDA)
ANDA 091620 · SANDOZ
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.
