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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020907
Company: AMNEAL

Products on NDA 020907

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	AB	Yes	Yes
ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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 020907

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/1998	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20907lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20907ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20907.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020907s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020907Orig1s030ltr.pdf
04/06/2020	SUPPL-25	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020907s025lbl.pdf
08/10/2021	SUPPL-22	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020907Orig1s020,s022ltr.pdf
08/10/2021	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020907s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020907Orig1s020,s022ltr.pdf
11/01/2017	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020907s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020907s019ltr.pdf
05/27/2016	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/12/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/08/2013	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020907s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020907Orig1s013ltr.pdf
12/28/2006	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009, s011ltr.pdf
12/28/2006	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009, s011ltr.pdf
07/26/2004	SUPPL-7		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020907_S007.pdf
09/13/2002	SUPPL-6	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020907_S006.pdf
06/30/2005	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020907s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020907s005ltr.pdf
11/14/2000	SUPPL-4	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S004.pdf
04/11/2000	SUPPL-3	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S003.pdf
02/10/2000	SUPPL-2	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S002.pdf
11/03/1999	SUPPL-1	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020907_S001.pdf

Labels for NDA 020907

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020907s030lbl.pdf
08/10/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020907s020s022lbl.pdf
04/06/2020	SUPPL-25	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020907s025lbl.pdf
11/01/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020907s019lbl.pdf
10/08/2013	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020907s013lbl.pdf
12/28/2006	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf
12/28/2006	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf
06/30/2005	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020907s005lbl.pdf
11/18/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20907lbl.pdf

Therapeutic Equivalents for NDA 020907

ACTIVELLA

TABLET;ORAL; 1MG;0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	Yes	AB	020907	AMNEAL
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	079193	BARR
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	078324	BRECKENRIDGE PHARM
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	210233	NAARI PTE LTD
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	210612	NOVAST LABS
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	207261	XIROMED

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