Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075548
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICROGESTIN 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription AB No No
MICROGESTIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG 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)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75548ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075548Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/30/2003 SUPPL-4 Labeling

Label is not available on this site.

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

Label is not available on this site.

07/23/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

10/24/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

MICROGESTIN 1.5/30

TABLET;ORAL-21; 0.03MG;1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 207581 AUROBINDO PHARMA LTD
GILDESS 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 077075 VINTAGE PHARMS LLC
HAILEY 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 209297 GLENMARK PHARMS
JUNEL 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 076381 BARR
LARIN 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 202996 NOVAST LABS
LOESTRIN 21 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription Yes AB 017875 APIL
LOESTRIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription Yes AB 017355 APIL
MICROGESTIN 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 075548 MAYNE PHARMA
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 202770 MYLAN LABS LTD

MICROGESTIN FE 1.5/30

TABLET;ORAL-28; 0.03MG;1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 207580 AUROBINDO PHARMA LTD
BLISOVI FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 201585 LUPIN LTD
GILDESS FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 077075 VINTAGE PHARMS LLC
HAILEY FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 209031 GLENMARK PHARMS
JUNEL FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 076064 BARR
LARIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 091453 NOVAST LABS
MICROGESTIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 075548 MAYNE PHARMA
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-28 Prescription No AB 202741 MYLAN LABS LTD

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