FDA.reportPublic FDA data

Application 020571

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAMPTOSARIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION40MG/2ML (20MG/ML)YesYes
002CAMPTOSARIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION100MG/5ML (20MG/ML)YesYes
003CAMPTOSARIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION300MG/15ML (20MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-1111Camptosaririnotecan hydrochloridePharmacia and Upjohn CompNDACurrent
0009-7529Camptosaririnotecan hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-7529Camptosaririnotecan hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-7529Camptosaririnotecan hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-7529Camptosaririnotecan hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-7529Camptosaririnotecan hydrochloridePharmacia & Upjohn Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78498SUPPL 2024-05-20
78497SUPPL 2024-05-20
69998SUPPL2022-01-31
69990SUPPL2022-01-31
61750SUPPL2020-01-31
61746SUPPL2020-01-31
57797SUPPL2019-02-25
57664ORIG2019-02-15
12756SUPPL2015-01-09
2762SUPPL2014-12-23
34870SUPPL2012-07-25
25213SUPPL2012-07-17
34869SUPPL2010-05-28
34868SUPPL2010-05-28
12755SUPPL2010-05-28
12754SUPPL2010-05-28
12753SUPPL2010-05-28
25212SUPPL2010-05-21
25211SUPPL2010-05-21
2761SUPPL2010-05-21
2760SUPPL2010-05-21
2759SUPPL2010-05-21
41439SUPPL2007-07-06
20731SUPPL2007-07-06
34867SUPPL2006-08-04
2758SUPPL2006-08-04
34866SUPPL2005-07-26
34865SUPPL2005-07-26
25210SUPPL2005-07-26
12752SUPPL2005-07-26
2757SUPPL2005-07-26
2755SUPPL2005-07-26
12751SUPPL2005-06-08
2756SUPPL2005-06-08
20732SUPPL2005-04-05
34864SUPPL2004-12-08
25209SUPPL2004-12-08
34863SUPPL2004-06-25
25208SUPPL2004-06-25
25207SUPPL2002-05-16
12750SUPPL2002-05-16
41441SUPPL2000-04-20
34862SUPPL2000-04-20
25206SUPPL2000-04-20
41440SUPPL1998-10-22
25205SUPPL1998-10-22
12749SUPPL1998-10-22
53105SUPPL1900-01-01
53104SUPPL1900-01-01
53103SUPPL1900-01-01