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 1/35-21 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 10/15/1974 | 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 |
|---|---|---|---|---|---|
| 02/21/2002 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2001 | SUPPL-90 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/05/2000 | SUPPL-88 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-87 | Labeling |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1998 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/1997 | SUPPL-82 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1996 | SUPPL-81 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-80 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1995 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1995 | SUPPL-78 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-77 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1994 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 11/04/1993 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-74 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-73 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/18/1991 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1991 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
| 10/23/1989 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 07/19/1989 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 10/28/1988 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1988 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1988 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 02/26/1987 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1985 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 04/05/1985 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 06/21/1984 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 01/30/1984 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 09/29/1983 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 06/15/1983 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 06/09/1983 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1980 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1980 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1980 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1980 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1979 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 12/05/1979 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 11/08/1979 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/1979 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/19/1979 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/24/1980 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1978 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1978 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1977 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1978 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1978 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/1977 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/12/1977 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/06/1977 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1976 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1976 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1976 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1976 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |