Orange Book product · Brand (NDA)
TAPAZOLE
METHIMAZOLE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
METHIMAZOLE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 007517
Product number
002
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.
- 2025METHIMAZOLEGeneric (ANDA)
ANDA 218830 · SQUARE PHARMS PLC
- 2023METHIMAZOLEGeneric (ANDA)
ANDA 218149 · BIONPHARMA
- 2023METHIMAZOLEGeneric (ANDA)
ANDA 209827 · MACLEODS PHARMS LTD
- 2012METHIMAZOLEGeneric (ANDA)
ANDA 202068 · RISING
- 2007METHIMAZOLEGeneric (ANDA)
ANDA 040734 · HERITAGE PHARMA
- 2007METHIMAZOLEGeneric (ANDA)
ANDA 040870 · SUN PHARM INDS INC
- 2005METHIMAZOLEGeneric (ANDA)
ANDA 040619 · DISCOVERY THERAP
- 2005METHIMAZOLEGeneric (ANDA)
ANDA 040547 · AIPING PHARM INC
- 2001METHIMAZOLEGeneric (ANDA)
ANDA 040411 · CHARTWELL RX
- 2000TAPAZOLEGeneric (ANDA)
ANDA 040320 · KING PHARMS LLC
- 2000METHIMAZOLEGeneric (ANDA)
ANDA 040350 · MYLAN
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.
