Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209260
Company: FRESENIUS KABI USA

Products on NDA 209260

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209260

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2018	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209260s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209260Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209260Orig1s0000TOC.cfm

Labels for NDA 209260

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209260s000lbl.pdf

Therapeutic Equivalents for NDA 209260

ATROPINE SULFATE

SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL; 8MG/20ML (0.4MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	Prescription	No	AP	213424	ACCORD HLTHCARE
ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	Prescription	Yes	AP	209260	FRESENIUS KABI USA
ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	Prescription	No	AP	213561	HIKMA