Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021146
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROPINE SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INTRAVENOUS Discontinued None Yes No
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
ATROPINE SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

ATROPINE SULFATE

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 Yes AP 021146 HOSPIRA
ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212461 INTL MEDICATION SYS

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 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 Yes AP 021146 HOSPIRA
ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212461 INTL MEDICATION SYS

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