Drugs@FDA: FDA-Approved Drugs
Company: ORTHO MCNEIL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORTHO-NOVUM 7/14-21 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 | Discontinued | None | No | No |
| ORTHO-NOVUM 7/14-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 04/04/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/03/2002 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/2002 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1995 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/04/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/18/1991 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/23/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/16/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/16/1990 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/18/1990 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1989 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1989 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/14/1989 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/17/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |