Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062889
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG 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 |
---|---|---|---|---|---|---|---|
04/25/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/14/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/30/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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04/26/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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06/18/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
06/26/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/21/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/29/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE
INJECTABLE;INJECTION; EQ 150MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLEOCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050441 | PFIZER |
CLEOCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062803 | PFIZER |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062800 | ALMAJECT |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062943 | ALMAJECT |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065346 | FRESENIUS KABI USA |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065347 | FRESENIUS KABI USA |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062889 | HIKMA |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065206 | HIKMA |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090108 | SAGENT PHARMS INC |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090109 | SAGENT PHARMS INC |