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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201787
Company: MACLEODS PHARMS LTD

Products on ANDA 201787

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201787

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2023	SUPPL-16	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/13/2020	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/08/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/23/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201787

DONEPEZIL HYDROCHLORIDE

TABLET, ORALLY DISINTEGRATING;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	205269	HISUN PHARM HANGZHOU
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	201787	MACLEODS PHARMS LTD

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	205269	HISUN PHARM HANGZHOU
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	201787	MACLEODS PHARMS LTD

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