Orange Book product · Generic (ANDA)
METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE
At a glance
Oct 27, 2017
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 27, 2017
8 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
METHADONE HYDROCHLORIDE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 208306
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METHADONE HYDROCHLORIDE
- —METHADOSEBrand (NDA)
NDA 017116 · SPECGX LLC
- —METHADONE HYDROCHLORIDEBrand (NDA)
NDA 021624 · MYLAN INSTITUTIONAL
- —METHADONE HYDROCHLORIDEBrand (NDA)
NDA 006383 · MALLINCKRODT INC
- —DOLOPHINE HYDROCHLORIDEBrand (NDA)
NDA 006134 · HIKMA
- —WESTADONEBrand (NDA)
NDA 017108 · SANDOZ
- —METHADONE HYDROCHLORIDEBrand (NDA)
NDA 017058 · HIKMA
- 2025METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 218609 · HIKMA
- 2024METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 218252 · BRECKENRIDGE
- 2021METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212094 · LANNETT CO INC
- 2020METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212093 · LANNETT CO INC
- 2020METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 090635 · THEPHARMANETWORK LLC
- 2020METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 204166 · VISTAPHARM LLC
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.
