Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071545
Company: ORTHO MCNEIL PHARM
Company: ORTHO MCNEIL PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORCEPT-E 1/35 21 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-21 | Discontinued | 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 |
---|---|---|---|---|---|---|---|
02/09/1989 | 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 |
---|---|---|---|---|---|
10/18/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/26/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |