Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040350
Company: MYLAN
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 Yes
METHIMAZOLE METHIMAZOLE 20MG TABLET;ORAL Discontinued None 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
03/29/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40350ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040350.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/18/2019 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

01/15/2016 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

07/11/2012 SUPPL-16 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040350s016lbl.pdf
09/28/2001 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/10/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/2001 SUPPL-4 Labeling

Label is not available on this site.

06/07/2001 SUPPL-3 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf
06/07/2001 SUPPL-2 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf
06/07/2001 SUPPL-1 Manufacturing (CMC)-New Strength Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/11/2012 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040350s016lbl.pdf

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

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