Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210931
Company: SHILPA
Company: SHILPA
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 |
---|---|---|---|---|---|---|---|
04/18/2019 | 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 |
---|---|---|---|---|---|
06/07/2021 | 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 | 209580 | AMNEAL |
BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210448 | APOTEX |
BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215102 | EUGIA PHARMA |
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 | 207050 | PHARMASCIENCE INC |
BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215235 | PRINSTON INC |
BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210931 | SHILPA |
BUSULFEX | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020954 | OTSUKA PHARM |