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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075256
Company: DURAMED PHARMS BARR

Products on ANDA 075256

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-21	Discontinued	None	No	No
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075256

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256_Desogestrel%20and%20Ethinyl%20Estradiol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75256ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075256_desogestrel_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-41	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-36	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/26/2016	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
04/13/2015	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
01/31/2013	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
11/26/2004	SUPPL-8	Labeling		Label is not available on this site.
06/19/2002	SUPPL-7	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75256S007_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75256S007_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075256s007_desogestrel_toc.cfm
07/27/2001	SUPPL-6	Manufacturing (CMC)-Manufacturing Process	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S006_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S006_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s006_desogestrel_toc.cfm
07/27/2001	SUPPL-5	Manufacturing (CMC)	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S005_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S005_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s005_desogestrel_toc.cfm
07/11/2001	SUPPL-4	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S004_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S004_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s004_desogestrel_toc.cfm
11/14/2001	SUPPL-3	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S003_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S003_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s003_desogestrel_toc.cfm
06/28/2001	SUPPL-2	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S002_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S002_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s002_desogestral_toc.cfm
10/28/1999	SUPPL-1	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256S001_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256S001_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075256s001_desogestrel_toc.cfm

Labels for ANDA 075256

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2002	SUPPL-7	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75256S007_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
11/14/2001	SUPPL-3	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S003_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
07/27/2001	SUPPL-6	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S006_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
07/27/2001	SUPPL-5	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S005_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
07/11/2001	SUPPL-4	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S004_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
06/28/2001	SUPPL-2	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S002_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
10/28/1999	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256S001_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
08/12/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256_Desogestrel%20and%20Ethinyl%20Estradiol_Prntlbl.pdf

Therapeutic Equivalents for ANDA 075256

DESOGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.15MG;0.03MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	075256	DURAMED PHARMS BARR
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	091234	NOVAST LABS
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	076915	WATSON LABS
ENSKYCE	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	201887	LUPIN LTD
ISIBLOOM	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	202789	XIROMED
KALLIGA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	207081	AUROBINDO PHARMA

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