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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202723
Company: DR REDDYS

Products on ANDA 202723

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202723

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2013	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202723Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202723Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/21/2019	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/21/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/20/2015	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 202723

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202723Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 202723

DONEPEZIL HYDROCHLORIDE

TABLET;ORAL; 23MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARICEPT	DONEPEZIL HYDROCHLORIDE	23MG	TABLET;ORAL	Prescription	Yes	AB	022568	EISAI INC
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET;ORAL	Prescription	No	AB	203713	DEXCEL
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET;ORAL	Prescription	No	AB	202723	DR REDDYS
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET;ORAL	Prescription	No	AB	202782	LUPIN LTD
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET;ORAL	Prescription	No	AB	202631	MACLEODS PHARMS LTD
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET;ORAL	Prescription	No	AB	203104	TWI PHARMS
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET;ORAL	Prescription	No	AB	203162	ZYDUS PHARMS

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