Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018206
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;0.75MG 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
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.

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.

05/14/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

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
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

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