Orange Book product · Generic (ANDA)
TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE
At a glance
Jan 31, 2011
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 2011
15 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
TRAMADOL HYDROCHLORIDE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 090404
Product number
001
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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- 1995ULTRAMBrand (NDA)
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ANDA 202075 · STRIDES PHARMA
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ANDA 208708 · RUBICON RESEARCH
- 2019TRAMADOL HYDROCHLORIDEGeneric (ANDA)
ANDA 211825 · UNICHEM
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- 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.
