FDA.reportPublic FDA data

Application 050317

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINCOCINLINCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 300MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0555Lincocinlincomycin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0555Lincocinlincomycin hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-0555Lincocinlincomycin hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-0555Lincocinlincomycin hydrochloridePharmacia & Upjohn Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70755SUPPL2022-04-12
70754SUPPL2022-04-12
56693SUPPL2018-12-07
56512SUPPL2018-11-20
53590SUPPL2018-04-02
53589SUPPL2018-04-02
45874SUPPL2016-11-10
45873SUPPL2016-11-10
45868SUPPL2016-11-10
45867SUPPL2016-11-10
7728SUPPL2014-10-21
17818SUPPL2014-10-16
30004SUPPL2008-02-29
38926SUPPL2008-02-28
7727SUPPL2004-06-07