Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017612
Company: PELAGIUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LO/OVRAL ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET;ORAL-21 Discontinued 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
03/17/1975 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

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-43 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
03/06/2002 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/08/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/03/2000 SUPPL-31 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18-782S023.pdf
11/29/1994 SUPPL-30 Labeling

Label is not available on this site.

01/28/1994 SUPPL-29 Labeling

Label is not available on this site.

12/23/1993 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/18/1989 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1988 SUPPL-26 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/08/1990 SUPPL-25 Labeling

Label is not available on this site.

07/15/1986 SUPPL-22 Labeling

Label is not available on this site.

02/19/1986 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1985 SUPPL-20 Labeling

Label is not available on this site.

01/07/1986 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1988 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1984 SUPPL-17 Labeling

Label is not available on this site.

02/19/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-15 Labeling

Label is not available on this site.

02/28/1980 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/22/1977 SUPPL-9 Labeling

Label is not available on this site.

11/20/1978 SUPPL-6 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017612s043,018206s021lbl.pdf

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