Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065442
Company: AUROBINDO PHARMA
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
08/26/2009 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-15 Labeling-Package Insert

Label is not available on this site.

08/19/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

08/19/2019 SUPPL-11 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.

01/16/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/27/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

05/20/2010 SUPPL-1 Labeling-Package Insert

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English