Drugs@FDA: FDA Approved Drug Products

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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 ANSYR PLASTIC SYRINGE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL Prescription None Yes Yes
ATROPINE SULFATE ANSYR PLASTIC SYRINGE ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL Prescription None Yes Yes
ATROPINE SULFATE ANSYR PLASTIC SYRINGE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL Prescription None Yes Yes
ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription None 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
11/01/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s019lbl.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
11/01/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s019lbl.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

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