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 1/50 21 | MESTRANOL; NORETHINDRONE | 0.05MG;1MG | TABLET;ORAL-21 | Discontinued | None | No | No |
| ORTHO-NOVUM 10-21 | MESTRANOL; NORETHINDRONE | 0.06MG;10MG | TABLET;ORAL-21 | Discontinued | None | No | No |
| ORTHO-NOVUM 2-21 | MESTRANOL; NORETHINDRONE | 0.1MG;2MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/21/1962 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 01/05/2000 | SUPPL-190 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/28/1998 | SUPPL-189 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/10/1998 | SUPPL-188 | Labeling |
Label is not available on this site. |
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| 01/29/1997 | SUPPL-186 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/09/1996 | SUPPL-185 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/30/1995 | SUPPL-183 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1995 | SUPPL-182 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/1994 | SUPPL-181 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/28/1994 | SUPPL-180 | Labeling |
Label is not available on this site. |
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| 11/04/1993 | SUPPL-179 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-178 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-177 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 03/18/1991 | SUPPL-175 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/16/1991 | SUPPL-174 | Labeling |
Label is not available on this site. |
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| 12/27/1996 | SUPPL-173 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/23/1989 | SUPPL-172 | Labeling |
Label is not available on this site. |
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| 07/19/1989 | SUPPL-171 | Labeling |
Label is not available on this site. |
||
| 10/28/1988 | SUPPL-170 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1988 | SUPPL-169 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-166 | Labeling |
Label is not available on this site. |
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| 02/26/1987 | SUPPL-165 | Labeling |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-164 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1985 | SUPPL-162 | Labeling |
Label is not available on this site. |
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| 04/05/1985 | SUPPL-161 | Labeling |
Label is not available on this site. |
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| 06/21/1984 | SUPPL-160 | Labeling |
Label is not available on this site. |
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| 01/30/1984 | SUPPL-159 | Labeling |
Label is not available on this site. |
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| 09/29/1983 | SUPPL-158 | Labeling |
Label is not available on this site. |
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| 09/14/1978 | SUPPL-105 | Labeling |
Label is not available on this site. |
||
| 03/29/1978 | SUPPL-87 | Unspecified |
Label is not available on this site. |
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| 07/25/1978 | SUPPL-86 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1977 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 07/01/1977 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 08/06/1976 | SUPPL-73 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1976 | SUPPL-72 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/07/1975 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-56 | Unspecified |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/03/1975 | SUPPL-50 | Unspecified |
Label is not available on this site. |