Orange Book product · Generic (ANDA)
TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE
At a glance
Nov 16, 2012
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 16, 2012
13 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
TRAMADOL HYDROCHLORIDE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 201973
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TRAMADOL HYDROCHLORIDE
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- 2005RYBIX ODTBrand (NDA)
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- 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
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.
