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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020631
Company: SPECGX LLC

Products on NDA 020631

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	1MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	2MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020631

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/1996	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
12/15/2023	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020631s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020631Orig1s003ltr.pdf
10/07/2019	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020631s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020631Orig1s002ltr.pdf
12/16/2016	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020631s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020631Orig1s001ltr.pdf

Labels for NDA 020631

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020631s003lbl.pdf
10/07/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020631s002lbl.pdf
12/16/2016	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020631s001lbl.pdf
12/16/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020631s001lbl.pdf

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