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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019999
Company: MERIDIAN MEDCL TECHN

Products on NDA 019999

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019999

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.

Labels for NDA 019999

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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