Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208888
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
02/17/2017 | 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 |
---|---|---|---|---|---|
07/12/2023 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
07/12/2023 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
DOXORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION; 20MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 208888 | AMNEAL |
DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062921 | HIKMA |
INJECTABLE;INJECTION; 50MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 208888 | AMNEAL |
DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062921 | HIKMA |
DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200170 | MYLAN LABS LTD |