Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040870
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHIMAZOLE METHIMAZOLE 5MG TABLET;ORAL Prescription AB No No
METHIMAZOLE METHIMAZOLE 10MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/25/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/18/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/15/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

METHIMAZOLE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHIMAZOLE METHIMAZOLE 5MG TABLET;ORAL Prescription No AB 040411 CASI PHARMS INC
METHIMAZOLE METHIMAZOLE 5MG TABLET;ORAL Prescription No AB 040547 ECI PHARMS LLC
METHIMAZOLE METHIMAZOLE 5MG TABLET;ORAL Prescription No AB 040734 HERITAGE PHARMA
METHIMAZOLE METHIMAZOLE 5MG TABLET;ORAL Prescription No AB 040350 MYLAN
METHIMAZOLE METHIMAZOLE 5MG TABLET;ORAL Prescription No AB 202068 RISING
METHIMAZOLE METHIMAZOLE 5MG TABLET;ORAL Prescription No AB 040870 SUN PHARM INDS INC
TAPAZOLE METHIMAZOLE 5MG TABLET;ORAL Prescription No AB 040320 KING PHARMS LLC

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHIMAZOLE METHIMAZOLE 10MG TABLET;ORAL Prescription No AB 040411 CASI PHARMS INC
METHIMAZOLE METHIMAZOLE 10MG TABLET;ORAL Prescription No AB 040547 ECI PHARMS LLC
METHIMAZOLE METHIMAZOLE 10MG TABLET;ORAL Prescription No AB 040734 HERITAGE PHARMA
METHIMAZOLE METHIMAZOLE 10MG TABLET;ORAL Prescription No AB 040350 MYLAN
METHIMAZOLE METHIMAZOLE 10MG TABLET;ORAL Prescription No AB 202068 RISING
METHIMAZOLE METHIMAZOLE 10MG TABLET;ORAL Prescription No AB 040870 SUN PHARM INDS INC
TAPAZOLE METHIMAZOLE 10MG TABLET;ORAL Prescription No AB 040320 KING PHARMS LLC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English