Drugs@FDA: FDA-Approved Drugs
Company: ORTHO MCNEIL JANSSEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORTHO-NOVUM 1/50 28 | MESTRANOL; NORETHINDRONE | 0.05MG;1MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/21/1968 | 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-128 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/2000 | SUPPL-126 | Labeling |
Label is not available on this site. |
||
| 01/05/2000 | SUPPL-125 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-124 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1998 | SUPPL-123 | Labeling |
Label is not available on this site. |
||
| 11/28/1997 | SUPPL-122 | Labeling |
Label is not available on this site. |
||
| 01/29/1997 | SUPPL-121 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1996 | SUPPL-120 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1995 | SUPPL-118 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1995 | SUPPL-117 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/1994 | SUPPL-116 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/06/1994 | SUPPL-115 | Labeling |
Label is not available on this site. |
||
| 11/04/1993 | SUPPL-114 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-113 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-112 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/18/1991 | SUPPL-110 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1991 | SUPPL-109 | Labeling |
Label is not available on this site. |
||
| 01/18/1990 | SUPPL-108 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/27/1996 | SUPPL-107 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1989 | SUPPL-106 | Labeling |
Label is not available on this site. |
||
| 07/19/1989 | SUPPL-105 | Labeling |
Label is not available on this site. |
||
| 10/28/1988 | SUPPL-104 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1988 | SUPPL-103 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-102 | Labeling |
Label is not available on this site. |
||
| 02/26/1987 | SUPPL-101 | Labeling |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-100 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1985 | SUPPL-98 | Labeling |
Label is not available on this site. |
||
| 04/05/1985 | SUPPL-97 | Labeling |
Label is not available on this site. |
||
| 06/21/1984 | SUPPL-96 | Labeling |
Label is not available on this site. |
||
| 01/30/1984 | SUPPL-95 | Labeling |
Label is not available on this site. |
||
| 09/29/1983 | SUPPL-94 | Labeling |
Label is not available on this site. |
||
| 11/08/1979 | SUPPL-84 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/15/1979 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 10/19/1979 | SUPPL-80 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/25/1978 | SUPPL-77 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1978 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 02/28/1978 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1978 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1978 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1978 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1978 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/19/1978 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1978 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/18/1978 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 07/25/1978 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1977 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 04/10/1979 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 08/09/1976 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1976 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1975 | SUPPL-21 | Unspecified |
Label is not available on this site. |