FDA.reportPublic FDA data

Application 050162

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEOCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 75MG BASEYesNo
002CLEOCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 150MG BASEYesNo
003CLEOCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 300MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0225Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0225Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0225Cleocin Hydrochlorideclindamycin hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-0225Cleocin Hydrochlorideclindamycin hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-0225Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0225Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0225Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0225Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0225Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0331Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0331Cleocin Hydrochlorideclindamycin hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-0331Cleocin Hydrochlorideclindamycin hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-0331Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0331Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0331Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0331Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0331Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0331Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0395Cleocin Hydrochlorideclindamycin hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-0395Cleocin Hydrochlorideclindamycin hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-0395Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0395Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0395Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0395Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0395Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0395Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0395Cleocin Hydrochlorideclindamycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
59762-3328clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3328clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3328clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3328clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3328clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3328clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3328clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3328clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3328clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5010clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5010clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5010clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5010clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5010clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5010clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5010clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5010clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5010clindamycin hydrochlorideclindamycin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
67296-1798Cleocin Hydrochlorideclindamycin hydrochlorideRedPharm Drug, Inc.NDACurrent
67296-1798Cleocin Hydrochlorideclindamycin hydrochlorideRedPharm Drug, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85585SUPPL 2026-03-30
85565SUPPL 2026-03-30
85083SUPPL 2026-02-19
85047SUPPL 2026-02-13
79253SUPPL 2024-07-30
79249SUPPL 2024-07-30
71159SUPPL2022-05-27
71122SUPPL2022-05-23
62108SUPPL2020-03-10
62100SUPPL2020-03-10
59076SUPPL2019-06-17
59070SUPPL2019-06-14
53065SUPPL2018-03-20
53043SUPPL2018-03-16
48278SUPPL2017-05-08
48277SUPPL2017-05-08
48238SUPPL2017-05-04
48237SUPPL2017-05-04
17807SUPPL2016-03-29
17806SUPPL2016-03-29
29993SUPPL2016-03-25
7707SUPPL2016-03-25
38921SUPPL2014-06-30
38920SUPPL2014-06-30
29992SUPPL2014-06-27
7706SUPPL2014-06-27
7705SUPPL2011-06-10
7704SUPPL2010-01-21
17805SUPPL2009-11-23
29991SUPPL2004-10-04
17804SUPPL2004-10-04
7703SUPPL2004-02-02