Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210739
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 2MG/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 |
---|---|---|---|---|---|---|---|
01/25/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ARSENIC TRIOXIDE
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210739 | AMNEAL |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210802 | AMRING PHARMS |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208231 | FRESENIUS KABI USA |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215059 | GLAND PHARMA LTD |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209315 | INGENUS PHARMS LLC |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209780 | NEXUS |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217413 | ORBICULAR |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209873 | PENN LIFE |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206228 | ZYDUS PHARMS |
INJECTABLE;INJECTION; 2MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210739 | AMNEAL |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214011 | EUGIA PHARMA |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215059 | GLAND PHARMA LTD |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217413 | ORBICULAR |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215359 | SANDOZ |
ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206228 | ZYDUS PHARMS |
TRISENOX | ARSENIC TRIOXIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 021248 | CEPHALON |