Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210197
Company: DEVA HOLDING AS
Company: DEVA HOLDING AS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | AP | No | No |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | AP | No | No |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | AP | No | No |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
01/12/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CEFTRIAXONE
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 250MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 210197 | DEVA HOLDING AS |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065305 | EPIC PHARMA LLC |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065342 | HIKMA FARMACEUTICA |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 203702 | QILU |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065169 | SANDOZ |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065391 | WOCKHARDT |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 500MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 210197 | DEVA HOLDING AS |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065305 | EPIC PHARMA LLC |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065342 | HIKMA FARMACEUTICA |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 203702 | QILU |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065169 | SANDOZ |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065391 | WOCKHARDT |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 1GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 210197 | DEVA HOLDING AS |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065305 | EPIC PHARMA LLC |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065342 | HIKMA FARMACEUTICA |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 203702 | QILU |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065169 | SANDOZ |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 2GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 210197 | DEVA HOLDING AS |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065305 | EPIC PHARMA LLC |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065342 | HIKMA FARMACEUTICA |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 203702 | QILU |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065169 | SANDOZ |
CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065391 | WOCKHARDT |