Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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 Prescription AB No No
TAPAZOLE 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
03/31/2000 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

TAPAZOLE

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

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