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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202259
Company: AM REGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUSULFAN BUSULFAN 6MG/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
12/22/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202259Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/04/2019 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/04/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

04/04/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

BUSULFAN

INJECTABLE;INJECTION; 6MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 210148 ACCORD HLTHCARE INC
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 202259 AM REGENT
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 209580 AMNEAL
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 210448 APOTEX
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 205106 ARTHUR GRP
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 205672 HOSPIRA
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 212127 MEITHEAL
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 208536 MYLAN INSTITUTIONAL
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 207794 NEXUS PHARMS
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 207050 PHARMASCIENCE INC
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 210931 SHILPA
BUSULFEX BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription Yes AP 020954 OTSUKA PHARM
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