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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040320
Company: KING PHARMS LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAPAZOLE METHIMAZOLE 5MG TABLET;ORAL Discontinued None No No
TAPAZOLE METHIMAZOLE 10MG 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
03/31/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40320ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/18/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
01/15/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
01/04/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
07/16/2012 SUPPL-5 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040320s005lbl.pdf
08/06/2004 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/16/2012 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040320s005lbl.pdf
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