Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018206
Company: CADENCE HEALTH
Company: CADENCE HEALTH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LO/OVRAL FE | ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE | 0.03MG,0.3MG;75MG | TABLET;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
07/26/1979 | 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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018206s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018206Orig1s022ltr.pdf | |
08/09/2017 | SUPPL-21 | 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 | |
10/18/2017 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018206s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018206Orig1s020ltr.pdf | |
03/06/2002 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/24/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
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05/03/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
11/29/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
06/08/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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05/14/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/23/1984 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
02/10/1984 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
02/17/1983 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
12/07/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018206s022lbl.pdf | |
10/18/2017 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018206s020lbl.pdf | |
08/09/2017 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017612s043,018206s021lbl.pdf |