Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063029
Company: ACP NIMBLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription AB No No
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription AB 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
09/20/1989 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
04/10/2012 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

08/20/2010 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

11/14/2005 SUPPL-23 Labeling

Label is not available on this site.

08/05/2005 SUPPL-17 Labeling

Label is not available on this site.

08/05/2005 SUPPL-16 Manufacturing (CMC)-New Strength

Label is not available on this site.

09/30/2004 SUPPL-15 Labeling

Label is not available on this site.

04/12/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/2000 SUPPL-12 Labeling

Label is not available on this site.

07/07/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

03/26/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/24/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/14/1998 SUPPL-7 Labeling

Label is not available on this site.

09/09/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/18/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/17/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/16/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLINDAMYCIN HYDROCHLORIDE

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription Yes AB 050162 PHARMACIA AND UPJOHN
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 063029 ACP NIMBLE
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 065442 AUROBINDO PHARMA
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 065194 EPIC PHARMA LLC
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 065242 LANNETT
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 065243 LANNETT CO INC
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 207402 MICRO LABS
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 065061 SUN PHARM INDS LTD
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 063083 WATSON LABS
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 065217 ZYDUS PHARMS USA

CAPSULE;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription Yes AB 050162 PHARMACIA AND UPJOHN
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 063029 ACP NIMBLE
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 065442 AUROBINDO PHARMA
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 065194 EPIC PHARMA LLC
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 065243 LANNETT CO INC
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 207402 MICRO LABS
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 065061 SUN PHARM INDS LTD
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 063083 WATSON LABS
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 065217 ZYDUS PHARMS USA

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