Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009388
Company: TEVA WOMENS
Company: TEVA WOMENS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIAMOX | ACETAZOLAMIDE SODIUM | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
06/25/1954 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/20/2024 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008943s053,009388s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/008943Orig1s053; 009388Orig1s039ltr.pdf | |
05/13/2022 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008943s052,009388s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/008943Orig1s052; 009388Orig1s038ltr.pdf | |
11/26/2002 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/03/1999 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/06/2000 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/1994 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/01/1994 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
12/09/1993 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/13/1990 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/05/1990 | SUPPL-25 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/20/2024 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008943s053,009388s039lbl.pdf | |
05/13/2022 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008943s052,009388s038lbl.pdf |