Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019999
Company: MERIDIAN MEDCL TECHN
Company: MERIDIAN MEDCL TECHN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MORPHINE SULFATE (AUTOINJECTOR) | MORPHINE SULFATE | 10MG/0.7ML (10MG/0.7ML) | 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 |
---|---|---|---|---|---|---|---|
07/12/1990 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
10/07/2019 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019999s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019999Orig1s023ltr.pdf | |
12/16/2016 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019999s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019999Orig1s021,s022ltr.pdf | |
12/16/2016 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019999s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019999Orig1s021,s022ltr.pdf | |
10/09/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/14/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/29/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/18/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/21/2000 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/14/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/13/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/23/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/28/1997 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/27/1996 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/07/2019 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019999s023lbl.pdf | |
10/07/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019999s023lbl.pdf | |
12/16/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019999s021s022lbl.pdf | |
12/16/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019999s021s022lbl.pdf |