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DOXORUBICIN

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

ADRIAMYCIN PFS (doxorubicin hydrochloride injection), Pharmacia & Upjohn Company NDA 50-467/S-064/S-067 & 50-629/S-010/S-013 Doxil (doxorubicin HCl liposome) Injection, ALZA NDA 50-718/S-016 12/17/02 | Doxil (doxorubicin HCl liposome) Injection, ALZA NDA 50-718/S-010 1/10/02 2/8/02 | Doxil (doxorubicin HCl liposome) Injection, 50 mg/m2, ALZA NDA 50-718/S-006 6/28/99 6/30/99 6/30/99 | Doxil Injection: treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens. Doxorubicin Hydrochloride Injection, 10, 20, 50, and 150 & 10, 20, 50, 75, 150, and 200 mg, Pharmacia & Upjohn Company NDA 50-467/S-068/S-069 & 50-629/S-014/S-016 | Doxil (doxorubicin HCl liposome) injection, Johnson & Johnson Pharma, Efficacy Supplement with Clinical Data to Support | Doxil (doxorubicin HCl liposome injection), Alza Corp, Accelerated Approval | Doxil (Doxorubicin HCI Liposomal Injection), Alza Corp., Accelerated Approval | Doxil (doxorubicin HCI ) Liposome Injection, Alza Corp., Labeling Revision & New or Modified Indication | DOXIL (doxorubicin hydrochloride) Injection, Alza Corp., Accelerated Approval | Adriamycin PFS (doxorubicin hydrochloride) Injection, Pfizer, Inc., Labeling Revision | Adriamycin RDF (doxorubicin hydrochloride) Injection, Pfizer, Inc., Labeling Revision | Doxorubicin Hydrochloride Injection, Onco Therapies Limited, Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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