Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ INC
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 | Yes |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/31/2012 | ORIG-1 | Approval | Not Applicable |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201692Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/18/2022 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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10/18/2022 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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10/18/2022 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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05/18/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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05/18/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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05/18/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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05/18/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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05/18/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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05/18/2020 | SUPPL-5 | 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 | 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 |