Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065361
Company: CIPLA LTD
Company: CIPLA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 200MG/100ML (2MG/ML) | 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 |
---|---|---|---|---|---|---|---|
10/22/2007 | 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 |
---|---|---|---|---|---|
01/27/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
01/27/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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12/20/2014 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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12/20/2014 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/20/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
EPIRUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION; 50MG/25ML (2MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELLENCE | EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 050778 | PFIZER INC |
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 065361 | CIPLA LTD |
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090163 | EPIC PHARMA LLC |
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 065289 | HIKMA |
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090075 | HISUN PHARM HANGZHOU |
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 065331 | IMPAX LABS INC |
INJECTABLE;INJECTION; 200MG/100ML (2MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELLENCE | EPIRUBICIN HYDROCHLORIDE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 050778 | PFIZER INC |
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 065361 | CIPLA LTD |
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 065289 | HIKMA |
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090075 | HISUN PHARM HANGZHOU |
EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 065331 | IMPAX LABS INC |