Application 050718

Type
NDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXIL (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDEINJECTABLE, LIPOSOMAL;INJECTION20MG/10ML (2MG/ML)YesNo
002DOXIL (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDEINJECTABLE, LIPOSOMAL;INJECTION50MG/25ML (2MG/ML)YesNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050718-001DOXIL (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17
N050718-002DOXIL (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N050718-001AB
N050718-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17782e0a99824c…
2021-12-28 21:50 UTC2021-12N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050718-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050718-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050718-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050718-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050718-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050718-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050718-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050718-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050718-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050718-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050718-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050718-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050718-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050718-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050718-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050718-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050718-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050718-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050718-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050718-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050718-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050718-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050718-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050718-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050718-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050718-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050718-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050718-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050718-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050718-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050718-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050718-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050718-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050718-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050718-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050718-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050718-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050718-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050718-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N050718-002AB1782e0a99824c…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXILDOXORUBICIN HYDROCHLORIDEBaxter Healthcare Corporation917eddf9-1d3f-4abe-8c81-d33b066e5bae2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050718
application number: NDA050718
DOXILDOXORUBICIN HYDROCHLORIDEBaxter Healthcare Company1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce2022-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050718
application number: NDA050718
ndc (product): 0338-0063
ndc (product): 0338-0067
Doxorubicin Hydrochloride LiposomeDOXORUBICIN HYDROCHLORIDE LIPOSOMEBaxter Healthcare Companycf25a018-e795-49e4-8533-a581f8366dd92022-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050718
application number: NDA050718
ndc (product): 0338-0080
ndc (product): 0338-0086

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0063DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0063DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0063DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0063DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0063DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0063DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0063DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0067DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0067DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0067DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0067DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0067DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0067DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0067DOXILdoxorubicin hydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0080Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0080Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0080Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0080Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0080Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0080Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0086Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0086Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0086Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0086Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0086Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
0338-0086Doxorubicin Hydrochloride LiposomeDoxorubicin Hydrochloride LiposomeBaxter Healthcare CorporationNDACurrent
59676-960DOXILdoxorubicin hydrochlorideJanssen Products, LPNDACurrent
59676-960DOXILdoxorubicin hydrochlorideJanssen Products, LPNDACurrent
59676-966Doxorubicin Hydrochloride liposomedoxorubicin hydrochlorideJanssen Products, LPNDACurrent
59676-966Doxorubicin Hydrochloride liposomedoxorubicin hydrochlorideJanssen Products, LPNDACurrent
59676-966Doxorubicin Hydrochloride liposomedoxorubicin hydrochlorideJanssen Products, LPNDACurrent
59676-966Doxorubicin Hydrochloride liposomedoxorubicin hydrochlorideJanssen Products, LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85359SUPPL 2026-03-12
85333SUPPL 2026-03-12
71041SUPPL2022-05-11
71027SUPPL2022-05-09
67007SUPPL2021-04-07
59694SUPPL2019-08-13
59692SUPPL2019-08-13
50611SUPPL2017-12-06
49020SUPPL2017-07-20
48428SUPPL2017-05-17
8095SUPPL2015-12-29
18106SUPPL2015-04-17
8094SUPPL2015-04-17
39176SUPPL2015-01-29
39175SUPPL2013-09-09
30356SUPPL2013-09-04
30355SUPPL2012-09-24
18105SUPPL2012-09-20
42688SUPPL2011-10-10
44786SUPPL2008-07-17
39174SUPPL2008-06-19
30354SUPPL2008-06-13
39172SUPPL2007-05-29
30353SUPPL2007-05-29
8093SUPPL2007-05-29
39173SUPPL2007-05-18
30352SUPPL2005-02-03
18104SUPPL2005-02-03
18103SUPPL2004-11-01
30351SUPPL2004-10-29
8092SUPPL2004-06-02
39171SUPPL1999-06-28
30350SUPPL1999-06-28