Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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

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
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204831 UNICHEM LABS 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
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091198 SANDOZ
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204831 UNICHEM LABS LTD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English