Drugs@FDA: FDA-Approved Drugs
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIAMOX | ACETAZOLAMIDE | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| DIAMOX | ACETAZOLAMIDE | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/27/1953 | 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 |
|---|---|---|---|---|---|
| 05/13/2022 | SUPPL-52 | 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 | |
| 01/05/1999 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/14/1991 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/28/1990 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 04/23/1990 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1990 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 12/06/1989 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 07/21/1988 | SUPPL-42 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/22/1988 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 08/11/1987 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/16/1987 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1987 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/1987 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/21/1986 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 09/25/1984 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1984 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/29/1982 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1982 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/12/1981 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/17/1980 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/17/1980 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/17/1980 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/1979 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/14/1984 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1979 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/1978 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/07/1978 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1978 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/09/1978 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1977 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1977 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/06/1977 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/28/1977 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/28/1977 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/13/2022 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008943s052,009388s038lbl.pdf |