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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018959
Company: HOSPIRA

Products on NDA 018959

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZINC CHLORIDE IN PLASTIC CONTAINER	ZINC CHLORIDE	EQ 1MG ZINC/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018959

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	Type 5 - New Formulation or New Manufacturer	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
04/25/2024	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018959s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018959Orig1s032ltr.pdf
06/12/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/14/2003	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18959slr011,008ltr.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.
02/14/2003	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18959slr011,008ltr.pdf
01/22/1999	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
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 018959

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2024	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018959s032lbl.pdf

Therapeutic Equivalents for NDA 018959

ZINC CHLORIDE IN PLASTIC CONTAINER

INJECTABLE;INJECTION; EQ 1MG ZINC/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZINC CHLORIDE	ZINC CHLORIDE	EQ 1MG ZINC/ML	INJECTABLE;INJECTION	Prescription	No	AP	212007	EXELA PHARMA
ZINC CHLORIDE	ZINC CHLORIDE	EQ 1MG ZINC/ML	INJECTABLE;INJECTION	Prescription	No	AP	217625	RK PHARMA
ZINC CHLORIDE	ZINC CHLORIDE	EQ 1MG ZINC/ML	INJECTABLE;INJECTION	Prescription	No	AP	216152	SOMERSET
ZINC CHLORIDE IN PLASTIC CONTAINER	ZINC CHLORIDE	EQ 1MG ZINC/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018959	HOSPIRA

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