Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202542
Company: PAR PHARM
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
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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202542Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/23/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/23/2015 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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 202415 ACTAVIS ELIZABETH
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 23MG TABLET;ORAL Prescription No AB 203713 DEXCEL PHARMA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 23MG TABLET;ORAL Prescription No AB 202723 DR REDDYS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 23MG TABLET;ORAL Prescription No AB 202410 HISUN PHARM HANGZHOU
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 23MG TABLET;ORAL Prescription No AB 203419 INDICUS PHARMA
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 202656 MYLAN
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 23MG TABLET;ORAL Prescription No AB 202542 PAR PHARM
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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