Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065194
Company: EPIC PHARMA LLC
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
03/22/2004 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
08/19/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

08/19/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/19/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

08/19/2019 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/19/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

02/10/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/10/2006 SUPPL-2 Labeling

Label is not available on this site.

11/14/2005 SUPPL-1 Labeling

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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