Drugs@FDA: FDA-Approved Drugs
Company: CADENCE HEALTH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LO/OVRAL | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-21 | 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 |
---|---|---|---|---|---|---|---|
03/17/1975 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
10/31/2022 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017612s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017612Orig1s045ltr.pdf | |
04/29/2022 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017612s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017612Orig1s044ltr.pdf | |
08/09/2017 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017612s043,018206s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017612Orig1s043,018206Orig1s021ltr.pdf | |
03/06/2002 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/08/1998 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/2000 | SUPPL-31 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18-782S023.pdf |
11/29/1994 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
01/28/1994 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
12/23/1993 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1989 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/27/1988 | SUPPL-26 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
08/08/1990 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
07/15/1986 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
02/19/1986 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/16/1985 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
01/07/1986 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/19/1988 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/26/1984 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
02/19/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/13/1984 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
02/28/1980 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
11/22/1977 | SUPPL-9 | Labeling |
Label is not available on this site. |
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11/20/1978 | SUPPL-6 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/31/2022 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017612s045lbl.pdf | |
04/29/2022 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017612s044lbl.pdf | |
08/09/2017 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017612s043,018206s021lbl.pdf |