Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214401
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/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 |
---|---|---|---|---|---|---|---|
04/05/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
INJECTABLE;INJECTION; EQ 6MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208084 | BAXTER HLTHCARE CORP |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203048 | RISING |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201692 | SANDOZ INC |
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214401 | HIKMA |
INJECTABLE;INJECTION; EQ 12MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208084 | BAXTER HLTHCARE CORP |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203048 | RISING |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201692 | SANDOZ INC |
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214401 | HIKMA |
INJECTABLE;INJECTION; EQ 18MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208084 | BAXTER HLTHCARE CORP |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203048 | RISING |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201692 | SANDOZ INC |
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214401 | HIKMA |