Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215624
Company: APOTEX

Products on ANDA 215624

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215624

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215624Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2026	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 215624

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