Orange Book product · Generic (ANDA)
TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE
At a glance
Nov 27, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 27, 2023
2 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
TRAMADOL HYDROCHLORIDE
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 208708
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TRAMADOL HYDROCHLORIDE
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- 2010CONZIPBrand (NDA)
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- 2008RYZOLTBrand (NDA)
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- 2005ULTRAM ERBrand (NDA)
NDA 021692 · VALEANT PHARMS
- 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
- 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.
