Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205269
Company: HISUN PHARM HANGZHOU
Company: HISUN PHARM HANGZHOU
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 |
---|---|---|---|---|---|---|---|
07/27/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/30/2019 | SUPPL-1 | Labeling-Container/Carton Labels, 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 |
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 |