Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETODOLAC | ETODOLAC | 400MG | TABLET;ORAL | Discontinued | None | No | No |
ETODOLAC | ETODOLAC | 500MG | 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 |
---|---|---|---|---|---|---|---|
11/26/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
05/09/2016 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/26/2010 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
09/22/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
03/02/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
02/24/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
12/02/1999 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/02/1999 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/28/1999 | SUPPL-6 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf |
12/28/1999 | SUPPL-5 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf |
12/28/1999 | SUPPL-4 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf |
12/28/1999 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf |
12/28/1999 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf |
04/30/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |