Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205184
Company: MYLAN LABS LTD
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
07/13/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/05/2019 SUPPL-1 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 205139 ACTAVIS LLC
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 ATHENEX INC
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 205672 HOSPIRA INC
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 202259 LUITPOLD
BUSULFAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 205184 MYLAN LABS LTD
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 MEDICARE LTD
BUSULFEX BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription Yes AP 020954 OTSUKA PHARM
MYLERAN BUSULFAN 6MG/ML INJECTABLE;INJECTION Prescription No AP 208536 MYLAN INSTITUTIONAL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English