FDA.reportPublic FDA data

Application 050467

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION10MG/VIALNoNo
002DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION50MG/VIALNoNo
003DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION20MG/VIALNoNo
004DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION150MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050467-001DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 1982
N050467-002DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 1982
N050467-003DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-20
N050467-004DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-22

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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050467-001DOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050467-002DOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050467-003DOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050467-004DOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050467-001DOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050467-002DOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050467-003DOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050467-004DOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050467-001DOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050467-002DOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050467-003DOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N050467-004DOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050467-001DOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050467-002DOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050467-003DOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050467-004DOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050467-001DOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050467-002DOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050467-003DOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050467-004DOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050467-001DOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050467-002DOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050467-003DOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050467-004DOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050467-001DOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050467-002DOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050467-003DOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050467-004DOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050467-001DOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050467-002DOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050467-003DOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050467-004DOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050467-001DOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050467-002DOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050467-003DOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050467-004DOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050467-001DOXORUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050467-002DOXORUBICIN HYDROCHLORIDE50MG/VIALINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050467-003DOXORUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION1985-05-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050467-004DOXORUBICIN HYDROCHLORIDE150MG/VIALINJECTABLE / INJECTION1987-07-224b0b4de00fa7…

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDEBluePoint Laboratories55889588-c5f1-d9bc-e063-6294a90a57912026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: doxorubicin hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEBluePoint Laboratoriesf6508535-e7a7-4e50-8d0c-43deda8d0d082026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxorubicin Hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Inc1fd148fb-0fbc-4b6f-b790-23546fb46a712026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxorubicin Hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Inc00634b2b-4e48-4178-8877-28582af894ad2026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxorubicin Hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDENorthStar RxLLCddf55319-bf62-4ec7-8be2-ef97188837c42026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxorubicin Hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.fbc48fa5-0bfb-4957-b13c-a56bb7a13b562026-04-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxorubicin Hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEBluePoint Laboratoriesada390ce-50ea-4de5-be58-5b03caf33c232026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXORUBICIN HYDROCHLORIDE
generic name: DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDEDr. Reddy's Laboratories Inc.0885dddf-727e-4692-92dd-a26c69cc278d2026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: doxorubicin hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.15a84bd6-b565-4722-bb92-e4c919620a902026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXORUBICIN HYDROCHLORIDE
generic name: DOXORUBICIN HYDROCHLORIDE
DOXILDOXORUBICIN HYDROCHLORIDEBaxter Healthcare Corporation917eddf9-1d3f-4abe-8c81-d33b066e5bae2026-03-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride LiposomeDOXORUBICIN HYDROCHLORIDESagent Pharmaceuticalsc8eb4784-36e0-483f-9e5d-af0552e49bb52026-02-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDELupin Pharmaceuticals, Inc.0f8eb9a1-74d0-47fd-94b8-a65b290065212025-11-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXORUBICIN HYDROCHLORIDE
generic name: DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDESagent Pharmaceuticalsae80bd3a-b99a-4e01-a444-b9d05687f00e2025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: doxorubicin hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDEAlembic Pharmaceuticals Limitedf8e001f5-441c-47cd-86f6-5d5e3de16bc02025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: doxorubicin hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Incd31d7f58-66d0-4826-b6b5-5914c031965f2025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxorubicin Hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEBluePoint Laboratoriesb8b66e93-0813-4876-b291-8d7c36a998072024-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXORUBICIN HYDROCHLORIDE
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEFresenius Kabi USA, LLCe0349f98-42fa-4003-b6d8-a1db1401b0ef2024-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxorubicin Hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEGland Pharma Limited74b14803-afc8-4a2e-ba92-43f1a72025eb2024-09-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxorubicin Hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDEActavis Pharma, Inc.33ddfdb1-b4bc-464d-a186-49c4b156279f2024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxorubicin hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin HydrochlorideDOXORUBICINAmneal Pharmaceuticals LLCd928625e-c1ef-4f25-8d25-764c8c6aab672024-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxorubicin Hydrochloride
generic name: DOXORUBICIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65071SUPPL2020-10-29
64451SUPPL2020-08-31
61440SUPPL2019-12-26
61389SUPPL2019-12-23
59670SUPPL2019-08-12
59664SUPPL2019-08-12
7762SUPPL2013-11-06
17840SUPPL2013-11-01
30041SUPPL2011-09-29
38948SUPPL2011-09-26
7761SUPPL2010-08-09
38947SUPPL2010-07-30
30040SUPPL2003-05-30
7760SUPPL2003-05-30
17839SUPPL2003-05-29
38946SUPPL2003-05-13
38945SUPPL2002-09-25
30039SUPPL2002-09-25
30038SUPPL2002-09-25
17838SUPPL2002-09-25