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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091198
Company: SANDOZ

Products on ANDA 091198

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 091198

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2011	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
12/19/2019	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/17/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/17/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091198

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
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	091198	SANDOZ

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
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	091198	SANDOZ

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