Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075640
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
01/28/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75640ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075640.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/06/2022 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
08/29/2012 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
05/10/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |