Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | Yes |
DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/17/1989 | 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 |
---|---|---|---|---|---|
01/19/2018 | SUPPL-26 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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07/25/2012 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062921s022lbl.pdf | |
11/18/2010 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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02/15/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
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07/28/2003 | SUPPL-15 | Labeling |
Label is not available on this site. |
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09/19/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
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08/24/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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12/01/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
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04/30/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
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07/29/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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02/24/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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02/24/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
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11/16/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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07/28/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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10/31/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/27/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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06/08/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/03/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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10/05/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/25/2012 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062921s022lbl.pdf |
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 |