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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018962
Company: HOSPIRA

Products on NDA 018962

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MANGANESE CHLORIDE IN PLASTIC CONTAINER	MANGANESE CHLORIDE	EQ 0.1MG MANGANESE/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018962

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/1986	ORIG-1	Approval		PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2023	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018962s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018962Orig1s030ltr.pdf
06/12/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
12/06/2002	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18962slr011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18962slr011ltr.pdf
02/16/2001	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/31/1999	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/22/1999	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
02/27/2004	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18962slr007ltr.pdf
08/29/1996	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
01/17/1997	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/29/1987	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/09/1986	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018962

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2023	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018962s030lbl.pdf
12/06/2002	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18962slr011lbl.pdf

Therapeutic Equivalents for NDA 018962

MANGANESE CHLORIDE IN PLASTIC CONTAINER

INJECTABLE;INJECTION; EQ 0.1MG MANGANESE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MANGANESE CHLORIDE	MANGANESE CHLORIDE	EQ 0.1MG MANGANESE/ML	INJECTABLE;INJECTION	Prescription	No	AP	217583	FRESENIUS KABI USA
MANGANESE CHLORIDE IN PLASTIC CONTAINER	MANGANESE CHLORIDE	EQ 0.1MG MANGANESE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018962	HOSPIRA

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