Drugs@FDA: FDA-Approved Drugs
Company: ADAPT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NARCAN | NALOXONE HYDROCHLORIDE | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| NARCAN | NALOXONE HYDROCHLORIDE | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| NARCAN | NALOXONE HYDROCHLORIDE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/13/1971 | 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 |
|---|---|---|---|---|---|
| 10/25/2002 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/2002 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/2002 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/2002 | SUPPL-54 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16636s52s54ltr.pdf | |
| 09/06/1996 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/2002 | SUPPL-52 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16636s52s54ltr.pdf | |
| 03/20/1995 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1995 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/1987 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1987 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1987 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1984 | SUPPL-39 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/17/1984 | SUPPL-38 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/25/1984 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1984 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 11/17/1983 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1983 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1992 | SUPPL-31 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/23/1983 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/14/1982 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/23/1982 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 05/19/1982 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/14/1981 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/14/1981 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1981 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/01/1981 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1981 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1980 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1979 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/20/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1976 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/08/1976 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/24/1975 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/06/1975 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/09/1974 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/05/1975 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/16/1975 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/04/1975 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1975 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/11/2002 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf | |
| 02/11/2002 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf |