Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203873
Company: AMNEAL PHARMS
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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