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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018206
Company: CADENCE HEALTH

Products on NDA 018206

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018206

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.
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.

Labels for NDA 018206

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

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