Orange Book product · Brand (NDA)
ULTRAM ER
TRAMADOL HYDROCHLORIDE
At a glance
Sep 08, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 08, 2005
21 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
TRAMADOL HYDROCHLORIDE
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 021692
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.
- 2020QDOLOBrand (NDA)
NDA 214044 · ROSEMONT
- 2010CONZIPBrand (NDA)
NDA 022370 · CIPHER PHARMS INC
- 2008RYZOLTBrand (NDA)
NDA 021745 · PURDUE PHARMA
- 2005RYBIX ODTBrand (NDA)
NDA 021693 · SHIONOGI INC
- 1995ULTRAMBrand (NDA)
NDA 020281 · JANSSEN PHARMS
- 2026TRAMADOL HYDROCHLORIDEGeneric (ANDA)
ANDA 202075 · STRIDES PHARMA
- 2025TRAMADOL HYDROCHLORIDEGeneric (ANDA)
ANDA 209404 · MACLEODS PHARMS LTD
- 2023TRAMADOL HYDROCHLORIDEGeneric (ANDA)
ANDA 208708 · RUBICON RESEARCH
- 2019TRAMADOL HYDROCHLORIDEGeneric (ANDA)
ANDA 211825 · UNICHEM
- 2019TRAMADOL HYDROCHLORIDEGeneric (ANDA)
ANDA 206706 · PURACAP LABS BLU
- 2015TRAMADOL HYDROCHLORIDEGeneric (ANDA)
ANDA 205257 · MYLAN
- 2015TRAMADOL HYDROCHLORIDEGeneric (ANDA)
ANDA 204421 · 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.
