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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075796
Company: DURAMED PHARMS BARR

Products on ANDA 075796

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVIANE-21	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-21	Discontinued	None	No	No
AVIANE-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075796

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2001	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-796_Aviane-21%20and%20Aviane-28_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75796ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-796_Aviane-21.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-28	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/17/2022	SUPPL-24	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
08/09/2017	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
03/30/2010	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
06/19/2002	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
05/15/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/03/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/31/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075796

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-796_Aviane-21%20and%20Aviane-28_prntlbl.pdf

Therapeutic Equivalents for ANDA 075796

AVIANE-21

There are no Therapeutic Equivalents.

AVIANE-28

TABLET;ORAL-28; 0.02MG;0.1MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFIRMELLE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	206886	AUROBINDO PHARMA LTD
AVIANE-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	075796	DURAMED PHARMS BARR
FALMINA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	090721	NOVAST LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	201108	AMNEAL PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	076625	MAYNE PHARMA
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	200245	MYLAN LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	207065	NAARI PTE LTD
VIENVA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	201088	XIROMED

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