Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062803
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEOCIN 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
10/16/1987 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
09/11/2017 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

08/18/2016 SUPPL-32 Labeling

Label is not available on this site.

08/18/2016 SUPPL-31 Labeling

Label is not available on this site.

08/18/2016 SUPPL-27 Labeling

Label is not available on this site.

08/18/2016 SUPPL-26 Labeling

Label is not available on this site.

08/18/2016 SUPPL-25 Labeling

Label is not available on this site.

04/05/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

10/01/1998 SUPPL-11 Labeling

Label is not available on this site.

02/02/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/30/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/23/1993 SUPPL-8 Labeling

Label is not available on this site.

01/12/1998 SUPPL-6 Labeling

Label is not available on this site.

07/06/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/30/1996 SUPPL-4 Labeling

Label is not available on this site.

03/22/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

CLEOCIN 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 PHARMACIA AND UPJOHN
CLEOCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062803 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062800 ALVOGEN INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062801 ALVOGEN INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062943 ALVOGEN INC
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 204748 MYLAN LABS LTD
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204749 MYLAN LABS LTD
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
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062889 WEST-WARD PHARMS INT
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065206 WEST-WARD PHARMS INT

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