Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203263
Company: SUN PHARM
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | AB | No | Yes |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/04/2013 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203263lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203263Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203263Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/26/2020 | SUPPL-27 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
11/03/2017 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
08/25/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
12/21/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
12/12/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/04/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203263lbl.pdf |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
INJECTABLE, LIPOSOMAL;INJECTION; 20MG/10ML (2MG/ML)
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXIL (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | Yes | AB | 050718 | BAXTER HLTHCARE CORP |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 207228 | AYANA PHARMA LTD |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 212219 | BAXTER HLTHCARE CORP |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 208657 | DR REDDYS |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 203263 | SUN PHARM |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 212299 | ZYDUS LIFESCIENCES |
INJECTABLE, LIPOSOMAL;INJECTION; 50MG/25ML (2MG/ML)
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXIL (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | Yes | AB | 050718 | BAXTER HLTHCARE CORP |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 207228 | AYANA PHARMA LTD |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 212219 | BAXTER HLTHCARE CORP |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 208657 | DR REDDYS |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 203263 | SUN PHARM |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 212299 | ZYDUS LIFESCIENCES |