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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018926
Company: PFIZER

Products on NDA 018926

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORQUEST FE	ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE	0.035MG;75MG;1MG	TABLET;ORAL-28	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018926

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/1986	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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-14	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018926s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018926Orig1s014ltr.pdf
05/08/2019	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017948s046,018926s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017802Orig1s034, 017948Orig1s046, 018926Orig1s013, 019190Orig1s049, 019192Orig1s048ltr.pdf
03/20/2018	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017948s045,018926s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018926Orig1s012,017948Orig1s045ltr.pdf
08/09/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018926s011,017948s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018926Orig1s011,017948Orig1s044ltr.pdf
06/02/1995	SUPPL-10	Labeling		Label is not available on this site.
07/31/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/19/1990	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
10/24/1989	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
05/17/1989	SUPPL-5	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/22/1989	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/02/1990	SUPPL-3	Labeling		Label is not available on this site.
01/14/1987	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018926

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-14	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018926s014lbl.pdf
05/08/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017948s046,018926s013lbl.pdf
03/20/2018	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017948s045,018926s012lbl.pdf
08/09/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018926s011,017948s044lbl.pdf

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