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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214652
Company: ACCORD HLTHCARE

Products on NDA 214652

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROPINE SULFATE	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214652

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2020	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214652s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214652Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214652Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2026	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214652s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214652Orig1s005ltr.pdf
02/18/2025	SUPPL-4	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214652Orig1s004ltr.pdf

Labels for NDA 214652

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2026	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214652s005lbl.pdf
09/29/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214652s000lbl.pdf

Therapeutic Equivalents for NDA 214652

ATROPINE SULFATE

SOLUTION;INTRAVENOUS; 1MG/ML (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/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	214652	ACCORD HLTHCARE
ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216120	AM REGENT
ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217345	HIKMA
ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215969	SOMERSET THERAPS LLC

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