Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040411
Company: CASI PHARMS 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
03/27/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40411ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/18/2019 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

01/15/2016 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

07/11/2012 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

08/22/2011 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/28/2011 SUPPL-12 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/08/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/2001 SUPPL-1 Labeling

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 PHARMS
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 PHARMS
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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