Orange Book product · Generic (ANDA)
MEXILETINE HYDROCHLORIDE
MEXILETINE HYDROCHLORIDE
At a glance
Oct 01, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 01, 2021
4 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
MEXILETINE HYDROCHLORIDE
Strength
150MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 214089
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MEXILETINE HYDROCHLORIDE
- 1985MEXITILBrand (NDA)
NDA 018873 · BOEHRINGER INGELHEIM
- 2026MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219987 · MACLEODS PHARMS LTD
- 2023MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215876 · QUAGEN
- 2022MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216463 · ANNORA PHARMA
- 2022MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215315 · RISING
- 2021MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214352 · INGENUS PHARMS LLC
- 2020MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213500 · CROSSMEDIKA SA
- 1998MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074865 · WATSON LABS
- 1997MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074711 · WATSON LABS
- 1996MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074450 · ANI PHARMS
- 1995MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074377 · TEVA
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.
