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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021146
Company: HOSPIRA

Products on NDA 021146

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROPINE SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
ATROPINE SULFATE	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021146

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/09/2001	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine%20Sulfate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine%20Sulfate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2025	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021146s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021146Orig1s037ltr.pdf
11/30/2020	SUPPL-25	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021146Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021146Orig1s025ltr.pdf
06/24/2020	SUPPL-22	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021146Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021146Orig1s022ltr.pdf
11/01/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s019lbl.pdf
08/17/2017	SUPPL-18	Manufacturing (CMC)-Control	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s018lbl.pdf
01/31/2017	SUPPL-16	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021146Orig1s016ltr.pdf
10/30/2015	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021146s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021146Orig1s015ltr.pdf
03/12/2014	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021146

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2025	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021146s037lbl.pdf
11/30/2020	SUPPL-25	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021146Orig1s025lbl.pdf
06/24/2020	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021146Orig1s022lbl.pdf
06/24/2020	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021146Orig1s022lbl.pdf
11/01/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s019lbl.pdf
08/17/2017	SUPPL-18	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s018lbl.pdf
10/30/2015	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021146s015lbl.pdf
07/09/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine%20Sulfate_prntlbl.pdf

Therapeutic Equivalents for NDA 021146

ATROPINE SULFATE

SOLUTION;INTRAVENOUS; 0.5MG/5ML (0.1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATROPINE SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212868	ACCORD HLTHCARE
ATROPINE SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215342	AMNEAL
ATROPINE SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021146	HOSPIRA

SOLUTION;INTRAVENOUS; 0.25MG/5ML (0.05MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATROPINE SULFATE	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212868	ACCORD HLTHCARE
ATROPINE SULFATE	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021146	HOSPIRA

SOLUTION;INTRAVENOUS; 1MG/10ML (0.1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212868	ACCORD HLTHCARE
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215342	AMNEAL
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021146	HOSPIRA
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212461	INTL MEDICATION SYS
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214970	MEDEFIL INC

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