Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 007517
Company: KING PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAPAZOLE METHIMAZOLE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
TAPAZOLE METHIMAZOLE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
06/21/1950 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/16/2001 SUPPL-22 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/007517s022lbl.pdf
11/17/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/25/1998 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1998 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/20/1995 SUPPL-18 Labeling

Label is not available on this site.

08/07/1992 SUPPL-17 Labeling

Label is not available on this site.

06/20/1991 SUPPL-16 Labeling

Label is not available on this site.

10/01/1991 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-14 Labeling

Label is not available on this site.

02/27/1990 SUPPL-13 Labeling

Label is not available on this site.

11/13/1990 SUPPL-12 Labeling

Label is not available on this site.

12/07/2007 SUPPL-11 Labeling

Label is not available on this site.

12/07/2007 SUPPL-10 Labeling

Label is not available on this site.

09/24/1985 SUPPL-9 Labeling

Label is not available on this site.

02/25/1983 SUPPL-8 Labeling

Label is not available on this site.

12/07/2007 SUPPL-6 Labeling

Label is not available on this site.

12/07/2007 SUPPL-5 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/16/2001 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/007517s022lbl.pdf

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