Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040547
Company: ECI PHARMS LLC
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
METHIMAZOLE METHIMAZOLE 20MG TABLET; ORAL Prescription None No No
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
02/18/2005 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-11 Labeling-Package Insert

Label is not available on this site.

01/15/2016 SUPPL-9 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 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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