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CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE CORP
Abbreviated New Drug Application (ANDA): 208084
Company: BAXTER HLTHCARE CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | 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 |
---|---|---|---|---|---|---|---|
06/28/2017 | 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 |
---|---|---|---|---|---|
05/14/2020 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
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 | 203048 | AKORN |
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 | 201692 | SANDOZ INC |
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 | 203048 | AKORN |
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 | 201692 | SANDOZ INC |
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 | 203048 | AKORN |
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 | 201692 | SANDOZ INC |
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