Orange Book product · Brand (NDA)
REVIA
NALTREXONE HYDROCHLORIDE
At a glance
Nov 20, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 1984
42 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
NALTREXONE HYDROCHLORIDE
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018932
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.
- 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
- 1999NALTREXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 075274 · ELITE LABS
- 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.
