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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020287-001FRAGMINDALTEPARIN SODIUM2,500IU/0.2ML (12,500IU/ML)INJECTABLE / SUBCUTANEOUSRLD1994-12-22
N020287-002FRAGMINDALTEPARIN SODIUM10,000IU/0.4ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUS2007-05-01
N020287-003FRAGMINDALTEPARIN SODIUM5,000IU/0.2ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD1996-03-18
N020287-004FRAGMINDALTEPARIN SODIUM10,000IU/ML (10,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD1998-01-30
N020287-005FRAGMINDALTEPARIN SODIUM7,500IU/0.3ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2002-04-04
N020287-006FRAGMINDALTEPARIN SODIUM95,000IU/3.8ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2002-04-04
N020287-007FRAGMINDALTEPARIN SODIUM95,000IU/9.5ML (10,000IU/ML)INJECTABLE / SUBCUTANEOUS2002-04-04
N020287-008FRAGMINDALTEPARIN SODIUM7,500 IU/0.75MLINJECTABLE / INJECTION2002-04-04
N020287-009FRAGMINDALTEPARIN SODIUM12,500IU/0.5ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-01
N020287-010FRAGMINDALTEPARIN SODIUM15,000IU/0.6ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-01
N020287-011FRAGMINDALTEPARIN SODIUM18,000IU/0.72ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-01
N020287-012FRAGMINDALTEPARIN SODIUM10,000IU/4ML (2,500IU/ML)INJECTABLE / SUBCUTANEOUSRLD2022-03-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 13 · 505 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020287-001FRAGMIN2,500IU/0.2ML (12,500IU/ML)INJECTABLE / SUBCUTANEOUSRLD1994-12-2284e616aacf4f…
2026-09-14 22:38:342026-08N020287-002FRAGMIN10,000IU/0.4ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUS2007-05-0184e616aacf4f…
2026-09-14 22:38:342026-08N020287-003FRAGMIN5,000IU/0.2ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD1996-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N020287-004FRAGMIN10,000IU/ML (10,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD1998-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N020287-005FRAGMIN7,500IU/0.3ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2002-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N020287-006FRAGMIN95,000IU/3.8ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2002-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N020287-007FRAGMIN95,000IU/9.5ML (10,000IU/ML)INJECTABLE / SUBCUTANEOUS2002-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N020287-008FRAGMIN7,500 IU/0.75MLINJECTABLE / INJECTION2002-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N020287-009FRAGMIN12,500IU/0.5ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-0184e616aacf4f…
2026-09-14 22:38:342026-08N020287-010FRAGMIN15,000IU/0.6ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-0184e616aacf4f…
2026-09-14 22:38:342026-08N020287-011FRAGMIN18,000IU/0.72ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-0184e616aacf4f…
2026-09-14 22:38:342026-08N020287-012FRAGMIN10,000IU/4ML (2,500IU/ML)INJECTABLE / SUBCUTANEOUSRLD2022-03-1584e616aacf4f…
2026-08-18 06:07:402026-07N020287-001FRAGMIN2,500IU/0.2ML (12,500IU/ML)INJECTABLE / SUBCUTANEOUSRLD1994-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-002FRAGMIN10,000IU/0.4ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUS2007-05-01caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-003FRAGMIN5,000IU/0.2ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD1996-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-004FRAGMIN10,000IU/ML (10,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD1998-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-005FRAGMIN7,500IU/0.3ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2002-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-006FRAGMIN95,000IU/3.8ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2002-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-007FRAGMIN95,000IU/9.5ML (10,000IU/ML)INJECTABLE / SUBCUTANEOUS2002-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-008FRAGMIN7,500 IU/0.75MLINJECTABLE / INJECTION2002-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-009FRAGMIN12,500IU/0.5ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-01caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-010FRAGMIN15,000IU/0.6ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-01caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-011FRAGMIN18,000IU/0.72ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-01caaa826d4ba7…
2026-08-18 06:07:402026-07N020287-012FRAGMIN10,000IU/4ML (2,500IU/ML)INJECTABLE / SUBCUTANEOUSRLD2022-03-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020287-001FRAGMIN2,500IU/0.2ML (12,500IU/ML)INJECTABLE / SUBCUTANEOUSRLD1994-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-002FRAGMIN10,000IU/0.4ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUS2007-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-003FRAGMIN5,000IU/0.2ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD1996-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-004FRAGMIN10,000IU/ML (10,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD1998-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-005FRAGMIN7,500IU/0.3ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2002-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-006FRAGMIN95,000IU/3.8ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2002-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-007FRAGMIN95,000IU/9.5ML (10,000IU/ML)INJECTABLE / SUBCUTANEOUS2002-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-008FRAGMIN7,500 IU/0.75MLINJECTABLE / INJECTION2002-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-009FRAGMIN12,500IU/0.5ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-010FRAGMIN15,000IU/0.6ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-011FRAGMIN18,000IU/0.72ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD2007-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020287-012FRAGMIN10,000IU/4ML (2,500IU/ML)INJECTABLE / SUBCUTANEOUSRLD2022-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020287-001FRAGMIN2,500IU/0.2ML (12,500IU/ML)INJECTABLE / SUBCUTANEOUSRLD1994-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020287-002FRAGMIN10,000IU/0.4ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUS2007-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020287-003FRAGMIN5,000IU/0.2ML (25,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD1996-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020287-004FRAGMIN10,000IU/ML (10,000IU/ML)INJECTABLE / SUBCUTANEOUSRLD1998-01-3031067a03dcf5…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 193 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-001NPP2022-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-002NPP2022-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-003NPP2022-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-004NPP2022-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-005NPP2022-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-006NPP2022-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-007NPP2022-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-008NPP2022-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-009NPP2022-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-010NPP2022-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020287-011NPP2022-05-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020287-001NPP2022-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020287-002NPP2022-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020287-003NPP2022-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020287-004NPP2022-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020287-005NPP2022-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020287-006NPP2022-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020287-007NPP2022-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020287-008NPP2022-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020287-009NPP2022-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020287-010NPP2022-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020287-011NPP2022-05-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020287-001NPP2022-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020287-002NPP2022-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020287-003NPP2022-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020287-004NPP2022-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020287-005NPP2022-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020287-006NPP2022-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020287-007NPP2022-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020287-008NPP2022-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020287-009NPP2022-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020287-010NPP2022-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020287-011NPP2022-05-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020287-001NPP2022-05-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020287-002NPP2022-05-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020287-003NPP2022-05-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020287-004NPP2022-05-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020287-005NPP2022-05-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020287-006NPP2022-05-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020287-007NPP2022-05-1674a2ff9319b5…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FragminDALTEPARIN SODIUMPfizer Laboratories Div Pfizer Inc23527b8b-9b28-4e6d-9751-33b143975ac72025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020287
application number: NDA020287
ndc (product): 0069-0253

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0253FragminDalteparin 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