Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200383
Company: NAARI PTE LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MG 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
04/07/2015 ORIG-1 Approval Not Applicable

Label is not available on this site.

NORGESTIMATE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MG TABLET;ORAL-28 Prescription No AB 200383 NAARI PTE LTD

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