Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075288
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOW-OGESTREL-21 ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET;ORAL-21 Discontinued None No No
LOW-OGESTREL-28 ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET;ORAL-28 Prescription AB 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
07/28/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75288_Norgestrel%20And%20Ethinyl%20Estradiol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75288ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075288_norgestrel-and-ethinyl-estradiol_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-21 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

06/24/2005 SUPPL-8 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/28/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75288_Norgestrel%20And%20Ethinyl%20Estradiol_Prntlbl.pdf

LOW-OGESTREL-21

There are no Therapeutic Equivalents.

LOW-OGESTREL-28

TABLET;ORAL-28; 0.03MG;0.3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CRYSELLE ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET;ORAL-28 Prescription No AB 075840 DURAMED PHARMS BARR
ELINEST ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET;ORAL-28 Prescription No AB 091105 NOVAST LABS LTD
LOW-OGESTREL-28 ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET;ORAL-28 Prescription No AB 075288 MAYNE PHARMA

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