Drugs@FDA: FDA-Approved Drugs
Company: ORTHO MCNEIL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MODICON 21 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 | Discontinued | None | No | No |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-108 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2001 | SUPPL-107 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/05/2000 | SUPPL-105 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-104 | Labeling |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-103 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1998 | SUPPL-102 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-101 | Labeling |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-100 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/1997 | SUPPL-99 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1996 | SUPPL-98 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-97 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1995 | SUPPL-96 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1995 | SUPPL-95 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-94 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1994 | SUPPL-93 | Labeling |
Label is not available on this site. |
||
| 11/04/1993 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-91 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-90 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/18/1991 | SUPPL-88 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1991 | SUPPL-87 | Labeling |
Label is not available on this site. |
||
| 10/23/1989 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 07/19/1989 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 10/28/1988 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1988 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 02/26/1987 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1985 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 04/05/1985 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 06/21/1984 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 01/30/1984 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 09/29/1983 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 06/15/1983 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 06/09/1983 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1980 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1980 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1980 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1980 | SUPPL-65 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/24/1980 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1979 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 08/15/1979 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 05/07/1979 | SUPPL-60 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/15/1979 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 10/19/1979 | SUPPL-58 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/01/1978 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 06/19/1979 | SUPPL-45 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/17/1978 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1978 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1977 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1978 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1978 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/18/1978 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/18/1978 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 01/18/1978 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 07/31/1978 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1977 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 12/23/1976 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1976 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1976 | SUPPL-21 | Manufacturing (CMC)-Packaging |
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. |