Orange Book product · Generic (ANDA)
NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE
At a glance
May 26, 1999
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 26, 1999
27 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
NALTREXONE HYDROCHLORIDE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 075274
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NALTREXONE HYDROCHLORIDE
- 1984REVIABrand (NDA)
NDA 018932 · TEVA WOMENS
- 2017NALTREXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 207905 · CHARTWELL
- 2012NALTREXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 090356 · SUN PHARM
- 2011NALTREXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 091205 · ACCORD HLTHCARE
- 2002NALTREXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 076264 · SPECGX LLC
- 2000NALTREXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 075434 · NOVITIUM PHARMA
- 1998NALTREXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 074918 · BARR
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.
