Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019999
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

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