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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021040
Company: TEVA WOMENS

Products on NDA 021040

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREFEST	ESTRADIOL; NORGESTIMATE	1MG,1MG;N/A,0.09MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021040

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/1999	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21040LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21040LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021040_s000_OrthoPrefestTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-15	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021040s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021040Orig1s015ltr.pdf
11/01/2017	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021040s013lbl.pdf
07/13/2004	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21040s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21040s012ltr.pdf
11/13/2002	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
01/23/2003	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr010ltr.pdf
12/19/2003	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf
10/30/2001	SUPPL-8	Labeling		Label is not available on this site.
12/19/2003	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf
01/18/2001	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/19/2003	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf
11/06/2000	SUPPL-3	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/19/2003	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf
12/19/2003	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf

Labels for NDA 021040

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-15	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021040s015lbl.pdf
02/15/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021040s015lbl.pdf
11/01/2017	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021040s013lbl.pdf
07/13/2004	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21040s012lbl.pdf
12/19/2003	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
12/19/2003	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
12/19/2003	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
12/19/2003	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
12/19/2003	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
10/22/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21040LBL.PDF

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