FDA.reportPublic FDA data

Application 020287

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS2,500IU/0.2ML (12,500IU/ML)YesNo
002FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS10,000IU/0.4ML (25,000IU/ML)NoNo
003FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS5,000IU/0.2ML (25,000IU/ML)YesNo
004FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS10,000IU/ML (10,000IU/ML)YesNo
005FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS7,500IU/0.3ML (25,000IU/ML)YesNo
006FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS95,000IU/3.8ML (25,000IU/ML)YesYes
007FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS95,000IU/9.5ML (10,000IU/ML)NoNo
008FRAGMINDALTEPARIN SODIUMINJECTABLE;INJECTION7,500 IU/0.75MLNoNo
009FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS12,500IU/0.5ML (25,000IU/ML)YesNo
010FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS15,000IU/0.6ML (25,000IU/ML)YesNo
011FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS18,000IU/0.72ML (25,000IU/ML)YesNo
012FRAGMINDALTEPARIN SODIUMINJECTABLE;SUBCUTANEOUS10,000IU/4ML (2,500IU/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0195FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0195FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0195FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0195FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0195FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0195FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0195FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0195FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0195FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0195FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0196FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0196FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0196FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0196FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0196FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0196FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0196FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0196FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0196FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0196FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0206FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0206FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0206FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0206FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0206FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0206FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0206FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0206FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0206FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0206FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0217FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0217FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0217FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0217FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0217FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0217FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0217FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0217FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0217FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0217FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0220FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0220FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0220FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0220FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0220FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0220FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0220FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0220FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0220FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0220FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0223FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0223FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0223FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0223FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0223FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0223FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0223FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0223FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0223FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0223FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0228FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0228FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0228FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0228FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0228FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0228FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0228FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0228FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0228FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0228FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0232FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0232FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0232FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0232FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0232FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0232FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0232FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0232FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0232FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0232FragminDalteparin SodiumPfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79934SUPPL 2024-12-02
80010SUPPL 2024-10-28
79997SUPPL 2024-10-25
79909SUPPL 2024-10-16
65549SUPPL2020-12-09
65517SUPPL2020-12-08
63787SUPPL2020-07-02
63786SUPPL2020-07-02
63751SUPPL2020-06-30
63750SUPPL2020-06-30
58767SUPPL2019-05-17
58751SUPPL2019-05-16
48406SUPPL2017-05-17
48370SUPPL2017-05-12
44997SUPPL2016-08-04
44987SUPPL2016-08-04
34480SUPPL2015-10-07
24741SUPPL2015-10-01
12420SUPPL2015-01-30
24740SUPPL2015-01-27
41270SUPPL2012-03-27
24739SUPPL2010-10-26
34479SUPPL2010-10-25
24738SUPPL2010-01-05
34478SUPPL2009-12-30
20586SUPPL2008-08-11
41268SUPPL2008-08-01
41267SUPPL2008-08-01
41269SUPPL2008-07-31
20590SUPPL2007-07-06
20589SUPPL2007-07-06
34477SUPPL2007-05-07
2302SUPPL2007-05-07
2301SUPPL2004-04-29
34476SUPPL2003-12-16
24737SUPPL2003-12-16
2300SUPPL2003-07-06
2296SUPPL2003-03-10
24736SUPPL2002-11-19
2299SUPPL2002-11-01
24735SUPPL2002-04-04
24734SUPPL2002-04-04
2298SUPPL2002-04-04
34475SUPPL2000-08-03
2297SUPPL2000-08-03
41266SUPPL1999-05-25
34474SUPPL1999-05-25
24733SUPPL1999-05-25
34473SUPPL1999-03-30
20588SUPPL1999-03-30
2295SUPPL1999-03-30
20587SUPPL1998-02-04
62923SUPPL1900-01-01