Drugs@FDA: FDA Approved Drug Products

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

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

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 091425 LUPIN LTD
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
ORSYTHIA ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 077099 VINTAGE PHARMS LLC
VIENVA ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 201088 SANDOZ INC

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