Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062801
Company: ALVOGEN INC
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
07/24/1987 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
06/13/2015 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

01/18/2013 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

10/08/2008 SUPPL-23 Labeling

Label is not available on this site.

08/12/2005 SUPPL-19 Labeling

Label is not available on this site.

04/16/2004 SUPPL-17 Labeling

Label is not available on this site.

04/09/2001 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/23/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/26/2000 SUPPL-13 Labeling

Label is not available on this site.

08/03/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/19/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/10/1995 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/24/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/11/1994 SUPPL-7 Labeling

Label is not available on this site.

10/30/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/08/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/22/1991 SUPPL-3 Labeling

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 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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