Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091105
Company: NOVAST LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELINEST 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
03/28/2012 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

ELINEST

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
NORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG TABLET;ORAL-28 Prescription No AB 201828 MYLAN LABS LTD

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