Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203873
Company: AMNEAL PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;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
05/12/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203873Orig1s000ltr.pdf

NORGESTIMATE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.025MG,0.025MG,0.025MG;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 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 203873 AMNEAL PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 204057 GLENMARK PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 200541 LUPIN PHARMS
TRI LO SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 076784 BARR LABS INC
TRI-LO-ESTARYLLA ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 091232 XIROMED
TRI-LO-MILI ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 205762 AUROBINDO PHARMA LTD

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