Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050162
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEOCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription AB Yes No
CLEOCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription AB Yes No
CLEOCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/22/1970 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2019 SUPPL-101 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050162s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050162Orig1s101ltr.pdf
03/15/2018 SUPPL-100 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050162s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050162Orig1s100ltr.pdf
05/02/2017 SUPPL-99 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050162s098s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050162Orig1s098,s099ltr.pdf
05/02/2017 SUPPL-98 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050162s098s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050162Orig1s098,s099ltr.pdf
08/02/2016 SUPPL-97 Labeling-Package Insert

Label is not available on this site.

03/23/2016 SUPPL-96 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050162Orig1s095,s096ltr.pdf
03/23/2016 SUPPL-95 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050162Orig1s095,s096ltr.pdf
01/21/2016 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

06/26/2014 SUPPL-93 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050162s092s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050162Orig1s092,s093ltr.pdf
06/26/2014 SUPPL-92 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050162s092s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050162Orig1s092,s093ltr.pdf
06/07/2011 SUPPL-90 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf
11/20/2009 SUPPL-85 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050162s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050162s085ltr.pdf
01/28/2004 SUPPL-84 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf
11/15/1999 SUPPL-83 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/29/2004 SUPPL-82 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50639s013ltr.pdf
02/24/1998 SUPPL-81 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/12/1997 SUPPL-80 Labeling

Label is not available on this site.

07/17/1997 SUPPL-79 Labeling

Label is not available on this site.

04/27/1982 SUPPL-77 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/03/1981 SUPPL-76 Efficacy-New Dosing Regimen

Label is not available on this site.

05/20/1981 SUPPL-75 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1980 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1980 SUPPL-73 Labeling

Label is not available on this site.

11/06/1979 SUPPL-72 Labeling

Label is not available on this site.

07/20/1979 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

07/09/1979 SUPPL-70 Labeling

Label is not available on this site.

07/09/1979 SUPPL-69 Labeling

Label is not available on this site.

05/18/1979 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1979 SUPPL-67 Labeling

Label is not available on this site.

10/04/1978 SUPPL-66 Labeling

Label is not available on this site.

06/28/1979 SUPPL-64 Labeling

Label is not available on this site.

07/11/1978 SUPPL-63 Labeling

Label is not available on this site.

02/14/1978 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/1977 SUPPL-61 Labeling

Label is not available on this site.

07/02/1976 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1976 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1976 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1977 SUPPL-57 Labeling

Label is not available on this site.

11/17/1975 SUPPL-56 Labeling

Label is not available on this site.

06/11/1975 SUPPL-55 Labeling

Label is not available on this site.

03/17/1975 SUPPL-54 Labeling

Label is not available on this site.

03/14/1975 SUPPL-53 Labeling

Label is not available on this site.

08/09/1974 SUPPL-52 Labeling

Label is not available on this site.

06/06/1974 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1974 SUPPL-50 Labeling

Label is not available on this site.

11/06/1973 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1973 SUPPL-47 Labeling

Label is not available on this site.

07/20/1973 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/24/1974 SUPPL-45 Labeling

Label is not available on this site.

04/24/1974 SUPPL-44 Labeling

Label is not available on this site.

04/03/1973 SUPPL-43 Labeling

Label is not available on this site.

07/19/1973 SUPPL-42 Labeling

Label is not available on this site.

01/12/1973 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1972 SUPPL-40 Labeling

Label is not available on this site.

07/14/1972 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1972 SUPPL-37 Labeling

Label is not available on this site.

05/11/1972 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1972 SUPPL-34 Labeling

Label is not available on this site.

02/15/1972 SUPPL-33 Labeling

Label is not available on this site.

05/22/1972 SUPPL-32 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/22/1971 SUPPL-29 Labeling

Label is not available on this site.

06/14/1971 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1972 SUPPL-27 Labeling

Label is not available on this site.

07/22/1971 SUPPL-24 Labeling

Label is not available on this site.

03/17/1997 SUPPL-22 Labeling

Label is not available on this site.

03/05/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/21/1995 SUPPL-20 Labeling

Label is not available on this site.

02/19/1971 SUPPL-19 Labeling

Label is not available on this site.

03/17/1997 SUPPL-18 Labeling

Label is not available on this site.

05/18/1971 SUPPL-17 Labeling

Label is not available on this site.

12/18/1970 SUPPL-16 Labeling

Label is not available on this site.

12/15/1970 SUPPL-15 Labeling

Label is not available on this site.

12/09/1970 SUPPL-14 Labeling

Label is not available on this site.

11/16/1970 SUPPL-13 Labeling

Label is not available on this site.

04/26/1971 SUPPL-12 Labeling

Label is not available on this site.

04/14/1988 SUPPL-11 Efficacy-New Dosing Regimen

Label is not available on this site.

10/20/1986 SUPPL-10 Labeling

Label is not available on this site.

03/17/1997 SUPPL-9 Labeling

Label is not available on this site.

06/21/1985 SUPPL-7 Labeling

Label is not available on this site.

09/21/1970 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/10/1985 SUPPL-5 Labeling

Label is not available on this site.

04/29/1983 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/01/1970 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1970 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2019 SUPPL-101 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050162s101lbl.pdf
03/15/2018 SUPPL-100 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050162s100lbl.pdf
05/02/2017 SUPPL-99 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050162s098s099lbl.pdf
05/02/2017 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050162s098s099lbl.pdf
03/23/2016 SUPPL-96 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf
03/23/2016 SUPPL-95 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf
06/26/2014 SUPPL-93 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050162s092s093lbl.pdf
06/26/2014 SUPPL-92 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050162s092s093lbl.pdf
11/20/2009 SUPPL-85 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050162s085lbl.pdf
09/29/2004 SUPPL-82 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf

CLEOCIN HYDROCHLORIDE

CAPSULE;ORAL; EQ 75MG 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 75MG BASE CAPSULE;ORAL Prescription Yes AB 050162 PHARMACIA AND UPJOHN
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065242 LANNETT
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065243 LANNETT CO INC
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 207402 MICRO LABS
CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065217 ZYDUS PHARMS USA

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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