Orange Book product · Brand (NDA)
MEXITIL
MEXILETINE HYDROCHLORIDE
At a glance
Dec 30, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 30, 1985
41 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
MEXILETINE HYDROCHLORIDE
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 018873
Product number
003
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.
- 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 214089 · SENORES PHARMS
- 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.
