Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208097
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE | NORETHINDRONE ACETATE;ETHINYL ESTRADIOL;ETHINYL ESTRADIOL;FERROUS FUMARATE | 75MG | TABLET;ORAL | None (Tentative Approval) | None | 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 |
---|---|---|---|---|---|---|---|
04/22/2016 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208097Orig1s000TAltr.pdf |