Drugs@FDA: FDA-Approved Drugs
Company: MERIDIAN MEDCL TECHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRALIDOXIME CHLORIDE (AUTOINJECTOR) | PRALIDOXIME CHLORIDE | 600MG/2ML (300MG/ML) | SOLUTION;INTRAMUSCULAR | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/1983 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/1983-018986ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/05/2015 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/2014 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/2013 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/2002 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/2002 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/2002 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/2002 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/2001 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/02/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/28/2001 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/06/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/23/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/31/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/21/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1986 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/06/1985 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |