Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050162
Company: PFIZER
Company: PFIZER
| 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 |
|---|---|---|---|---|---|
| 05/20/2022 | SUPPL-104 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050162s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050162Orig1s104ltr.pdf | |
| 03/09/2020 | SUPPL-102 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050162s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050162Orig1s102ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 05/20/2022 | SUPPL-104 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050162s104lbl.pdf | |
| 03/09/2020 | SUPPL-102 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050162s102lbl.pdf | |
| 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 | PFIZER |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065243 | CHARTWELL MOLECULAR |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 216957 | GLENMARK PHARMS LTD |
| 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 | 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 | PFIZER |
| 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 | 063029 | COSETTE |
| 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 | 216957 | GLENMARK PHARMS LTD |
| 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 | 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 | 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 | PFIZER |
| 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 | 063029 | COSETTE |
| 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 | 216957 | GLENMARK PHARMS LTD |
| 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 | 065217 | ZYDUS PHARMS USA |