Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090768
Company: JUBILANT GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG 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
05/31/2011 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
07/15/2016 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

07/15/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

DONEPEZIL HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARICEPT DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 020690 EISAI INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078662 ACI HEALTHCARE LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 201724 ALEMBIC PHARMS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090056 AUROBINDO
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090100 CADILA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204609 CADILA PHARMS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077518 CIPLA LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202114 CSPC OUYI
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 201001 DR REDDYS LABS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077344 HERITAGE PHARMA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203034 HETERO LABS LTD V
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 201634 INDICUS PHARMA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090768 JUBILANT GENERICS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 201146 MACLEODS PHARMS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090521 MYLAN PHARMS INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090425 PLIVA HRVATSKA DOO
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 200292 PRINSTON INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090290 SANDOZ
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203907 SCIEGEN PHARMS INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090551 STRIDES PHARMA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090493 SUN PHARM INDS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090686 TORRENT PHARMS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203656 UNICHEM LABS LTD

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARICEPT DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 020690 EISAI INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078662 ACI HEALTHCARE LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 201724 ALEMBIC PHARMS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090056 AUROBINDO
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090100 CADILA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 204609 CADILA PHARMS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077518 CIPLA LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202114 CSPC OUYI
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 201001 DR REDDYS LABS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077344 HERITAGE PHARMA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 203034 HETERO LABS LTD V
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 201634 INDICUS PHARMA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090768 JUBILANT GENERICS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 201146 MACLEODS PHARMS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090521 MYLAN PHARMS INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090425 PLIVA HRVATSKA DOO
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 200292 PRINSTON INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090290 SANDOZ
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 203907 SCIEGEN PHARMS INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090551 STRIDES PHARMA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090493 SUN PHARM INDS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090686 TORRENT PHARMS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 203656 UNICHEM LABS LTD

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