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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206289
Company: RISING

Summary Review

Products on NDA 206289

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROPINE SULFATE	ATROPINE SULFATE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT1	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206289

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/2014	ORIG-1	Approval	Type 7 - Drug Already Marketed without Approved NDA	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206289s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206289Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2025	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206289s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/206289Orig1s014ltr.pdf
03/18/2022	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206289Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206289Orig1s011ltr.pdf

Labels for NDA 206289

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2025	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206289s014lbl.pdf
03/18/2022	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206289Orig1s011lbl.pdf
07/18/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206289s000lbl.pdf

Therapeutic Equivalents for NDA 206289

ATROPINE SULFATE

SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATROPINE SULFATE	ATROPINE SULFATE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	214752	AMNEAL
ATROPINE SULFATE	ATROPINE SULFATE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	215624	APOTEX
ATROPINE SULFATE	ATROPINE SULFATE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	219013	EDENBRIDGE PHARMS
ATROPINE SULFATE	ATROPINE SULFATE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	218148	MANKIND PHARMA
ATROPINE SULFATE	ATROPINE SULFATE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT1	206289	RISING
ATROPINE SULFATE	ATROPINE SULFATE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	215618	SOMERSET THERAPS LLC

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