Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| APRESOLINE | HYDRALAZINE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/15/1953 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/1999 | SUPPL-71 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/03/1997 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/1996 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1996 | SUPPL-68 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf | |
| 07/12/1994 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/27/1993 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/03/1992 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/05/1991 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1991 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1989 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 12/22/1986 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 09/13/1985 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 03/19/1985 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1984 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/15/1983 | SUPPL-53 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/15/1983 | SUPPL-52 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/15/1983 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/23/1982 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1982 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/18/1985 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 02/27/1981 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 05/08/1980 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 01/25/1980 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/31/1979 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/02/1979 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/29/1979 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1979 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/09/1979 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/09/1979 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/04/1979 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 10/04/1979 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 09/07/1977 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1977 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/18/1977 | SUPPL-31 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/18/1977 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 04/18/1977 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/11/1977 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1976 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/11/1977 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 07/11/1977 | SUPPL-21 |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/1996 | SUPPL-68 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf |