Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040320
Company: KING PHARMS LLC
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 |