Application 022234

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOCETAXELDOCETAXELINJECTABLE;INJECTION20MG/2ML (10MG/ML)YesYes
002DOCETAXELDOCETAXELINJECTABLE;INJECTION80MG/8ML (10MG/ML)YesYes
003DOCETAXELDOCETAXELINJECTABLE;INJECTION160MG/16ML (10MG/ML)YesYes
004DOCETAXELDOCETAXELINJECTABLE;INJECTION20MG/ML (20MG/ML)YesNo
005DOCETAXELDOCETAXELINJECTABLE;INJECTION80MG/4ML (20MG/ML)YesNo
006DOCETAXELDOCETAXELINJECTABLE;INJECTION120MG/6ML (20MG/ML)YesNo
007DOCETAXELDOCETAXELINJECTABLE;INJECTION160MG/8ML (20MG/ML)YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022234-001DOCETAXELDOCETAXEL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08
N022234-002DOCETAXELDOCETAXEL80MG/8ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08
N022234-003DOCETAXELDOCETAXEL160MG/16ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08
N022234-004DOCETAXELDOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23
N022234-005DOCETAXELDOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23
N022234-006DOCETAXELDOCETAXEL120MG/6ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23
N022234-007DOCETAXELDOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONRLD2017-01-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N022234-001AP
N022234-002AP
N022234-003AP

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 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022234-001DOCETAXEL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022234-002DOCETAXEL80MG/8ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022234-003DOCETAXEL160MG/16ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022234-004DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022234-005DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022234-006DOCETAXEL120MG/6ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022234-007DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONRLD2017-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022234-001DOCETAXEL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022234-002DOCETAXEL80MG/8ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022234-003DOCETAXEL160MG/16ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022234-004DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022234-005DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022234-006DOCETAXEL120MG/6ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022234-007DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONRLD2017-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N022234-001DOCETAXEL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022234-002DOCETAXEL80MG/8ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022234-003DOCETAXEL160MG/16ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022234-004DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022234-005DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022234-006DOCETAXEL120MG/6ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022234-007DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONRLD2017-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022234-001DOCETAXEL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022234-002DOCETAXEL80MG/8ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022234-003DOCETAXEL160MG/16ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022234-004DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022234-005DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022234-006DOCETAXEL120MG/6ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022234-007DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONRLD2017-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022234-001DOCETAXEL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022234-002DOCETAXEL80MG/8ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022234-003DOCETAXEL160MG/16ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022234-004DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022234-005DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022234-006DOCETAXEL120MG/6ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022234-007DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONRLD2017-01-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022234-001DOCETAXEL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022234-002DOCETAXEL80MG/8ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022234-003DOCETAXEL160MG/16ML (10MG/ML)INJECTABLE / INJECTIONAPRLD, RS2011-03-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022234-004DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022234-005DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONRLD2016-06-2303ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022234-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022234-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022234-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022234-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022234-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022234-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022234-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022234-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022234-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022234-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022234-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022234-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022234-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022234-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022234-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022234-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022234-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022234-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022234-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022234-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022234-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022234-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022234-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022234-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022234-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022234-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022234-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022234-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022234-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022234-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022234-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022234-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022234-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022234-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022234-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022234-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022234-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022234-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022234-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022234-001AP18072bd15b7f6…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DocetaxelDOCETAXELHospira, Inc.6b9999bb-869e-4d25-838c-23c3ab2800442025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022234
application number: NDA022234
ndc (product): 0409-5068
ndc (product): 0409-4235
ndc (product): 0409-0365
DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.644c5035-20d2-4686-beaa-bef08e99051c2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022234
application number: NDA022234
ndc (product): 0409-7870
ndc (product): 0409-1732
DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.00c61d11-d6b7-4618-b6f6-2592dbcc8af72025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022234
application number: NDA022234
ndc (product): 0409-0016
ndc (product): 0409-2026
DocetaxelDOCETAXELHospira, Inc.3104aab1-cd6e-4ad2-8e0a-286a0c5d19402024-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022234
application number: NDA022234
ndc (product): 0409-0366
ndc (product): 0409-0367
ndc (product): 0409-0368
DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.a0ec4bcc-93ea-4c41-a4b6-95ec194918072024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022234
application number: NDA022234
ndc (product): 0409-0201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-0016DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0365DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0365DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-1732DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-2026DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-4235DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-4235DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-5068DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-7870DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-7870DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74268SUPPL 2023-05-16
74260SUPPL 2023-05-16
65355SUPPL2020-11-27
65331SUPPL2020-11-25
60561SUPPL2019-10-15
60560SUPPL2019-10-15
60559SUPPL2019-10-15
60557SUPPL2019-10-15
60556SUPPL2019-10-15
60555SUPPL2019-10-15
55748SUPPL2018-10-01
55620SUPPL2018-09-26
55106SUPPL2018-08-03
55095SUPPL2018-08-03
49889SUPPL2017-09-29
49874SUPPL2017-09-28
49666SUPPL2017-09-06
29432SUPPL2014-07-11
17108SUPPL2014-07-11
44709ORIG2011-12-08
42459ORIG2011-12-08
17107ORIG2011-03-11
7075ORIG2011-03-11
7074ORIG2008-08-13