Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075647
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICROGESTIN 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription AB No No
MICROGESTIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG 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
02/05/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75647ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/30/2003 SUPPL-5 Labeling

Label is not available on this site.

11/07/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

11/18/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

09/04/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

MICROGESTIN 1/20

TABLET;ORAL-21; 0.02MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 207506 AUROBINDO PHARMA LTD
GILDESS 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 077077 VINTAGE PHARMS LLC
JUNEL 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 076380 BARR
LARIN 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 202995 NOVAST LABS
LOESTRIN 21 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription Yes AB 017876 APIL
MICROGESTIN 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 075647 MAYNE PHARMA
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 206969 GLENMARK PHARMS LTD
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 202771 MYLAN LABS LTD

MICROGESTIN FE 1/20

TABLET;ORAL-28; 0.02MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 207505 AUROBINDO PHARMA LTD
BLISOVI FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 201584 LUPIN LTD
GILDESS FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 077077 VINTAGE PHARMS LLC
HAILEY FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 206597 GLENMARK PHARMS LTD
JUNEL FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 076081 BARR
LARIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 091454 NOVAST LABS
LOESTRIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription Yes AB 017354 APIL
MICROGESTIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 075647 MAYNE PHARMA
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 202772 MYLAN LABS LTD

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