Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017948
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORMINEST FE ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE 0.035MG;0.5MG;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
02/21/1978 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
05/08/2019 SUPPL-46 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-45 Labeling-Package Insert Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018926Orig1s012,017948Orig1s045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/017948s045,018926s012lbl.pdf
08/09/2017 SUPPL-44 Labeling-Patient 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-43 Labeling

Label is not available on this site.

07/31/1992 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

09/19/1990 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1990 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1989 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1989 SUPPL-37 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/31/1988 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

11/02/1990 SUPPL-35 Labeling

Label is not available on this site.

11/13/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/12/1984 SUPPL-32 Labeling

Label is not available on this site.

09/27/1984 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1984 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1981 SUPPL-25 Labeling

Label is not available on this site.

08/10/1981 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1981 SUPPL-23 Labeling

Label is not available on this site.

08/10/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1981 SUPPL-21 Labeling

Label is not available on this site.

08/10/1981 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1981 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1980 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1980 SUPPL-12 Labeling

Label is not available on this site.

05/13/1980 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/13/1980 SUPPL-10 Labeling

Label is not available on this site.

07/18/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/26/1978 SUPPL-2 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
05/08/2019 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017948s046,018926s013lbl.pdf
08/09/2017 SUPPL-44 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018926s011,017948s044lbl.pdf

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