Application 050467

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/VIAL	No	No
002	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/VIAL	No	No
003	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/VIAL	No	No
004	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	150MG/VIAL	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050467-001	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982
N050467-002	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982
N050467-003	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20
N050467-004	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050467-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050467-002	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050467-003	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050467-004	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050467-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050467-002	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050467-003	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050467-004	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050467-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050467-002	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050467-003	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050467-004	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050467-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050467-002	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050467-003	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050467-004	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050467-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050467-002	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050467-003	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050467-004	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050467-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050467-002	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050467-003	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050467-004	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050467-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050467-002	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050467-003	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050467-004	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050467-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050467-002	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050467-003	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050467-004	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050467-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050467-002	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050467-003	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050467-004	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050467-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050467-002	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050467-003	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION		1985-05-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050467-004	DOXORUBICIN HYDROCHLORIDE	150MG/VIAL	INJECTABLE / INJECTION		1987-07-22	`ea99ee380514…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxorubicin hydrochloride	DOXORUBICIN HYDROCHLORIDE	BluePoint Laboratories	55889588-c5f1-d9bc-e063-6294a90a5791	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: doxorubicin hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	BluePoint Laboratories	f6508535-e7a7-4e50-8d0c-43deda8d0d08	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Pfizer Laboratories Div Pfizer Inc	1fd148fb-0fbc-4b6f-b790-23546fb46a71	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Pfizer Laboratories Div Pfizer Inc	00634b2b-4e48-4178-8877-28582af894ad	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	NorthStar RxLLC	ddf55319-bf62-4ec7-8be2-ef97188837c4	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	fbc48fa5-0bfb-4957-b13c-a56bb7a13b56	2026-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	BluePoint Laboratories	ada390ce-50ea-4de5-be58-5b03caf33c23	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXORUBICIN HYDROCHLORIDE generic name: DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride	DOXORUBICIN HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	0885dddf-727e-4692-92dd-a26c69cc278d	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: doxorubicin hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	15a84bd6-b565-4722-bb92-e4c919620a90	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXORUBICIN HYDROCHLORIDE generic name: DOXORUBICIN HYDROCHLORIDE
DOXIL	DOXORUBICIN HYDROCHLORIDE	Baxter Healthcare Corporation	917eddf9-1d3f-4abe-8c81-d33b066e5bae	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride Liposome	DOXORUBICIN HYDROCHLORIDE	Sagent Pharmaceuticals	c8eb4784-36e0-483f-9e5d-af0552e49bb5	2026-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	0f8eb9a1-74d0-47fd-94b8-a65b29006521	2025-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXORUBICIN HYDROCHLORIDE generic name: DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride	DOXORUBICIN HYDROCHLORIDE	Sagent Pharmaceuticals	ae80bd3a-b99a-4e01-a444-b9d05687f00e	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: doxorubicin hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride	DOXORUBICIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	f8e001f5-441c-47cd-86f6-5d5e3de16bc0	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: doxorubicin hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Pfizer Laboratories Div Pfizer Inc	d31d7f58-66d0-4826-b6b5-5914c031965f	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	BluePoint Laboratories	b8b66e93-0813-4876-b291-8d7c36a99807	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXORUBICIN HYDROCHLORIDE generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	e0349f98-42fa-4003-b6d8-a1db1401b0ef	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Gland Pharma Limited	74b14803-afc8-4a2e-ba92-43f1a72025eb	2024-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin Hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin hydrochloride	DOXORUBICIN HYDROCHLORIDE	Actavis Pharma, Inc.	33ddfdb1-b4bc-464d-a186-49c4b156279f	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxorubicin hydrochloride generic name: DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride	DOXORUBICIN	Amneal Pharmaceuticals LLC	d928625e-c1ef-4f25-8d25-764c8c6aab67	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name 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
Document	Submission type	Date
65071	SUPPL	2020-10-29
64451	SUPPL	2020-08-31
61440	SUPPL	2019-12-26
61389	SUPPL	2019-12-23
59670	SUPPL	2019-08-12
59664	SUPPL	2019-08-12
7762	SUPPL	2013-11-06
17840	SUPPL	2013-11-01
30041	SUPPL	2011-09-29
38948	SUPPL	2011-09-26
7761	SUPPL	2010-08-09
38947	SUPPL	2010-07-30
30040	SUPPL	2003-05-30
7760	SUPPL	2003-05-30
17839	SUPPL	2003-05-29
38946	SUPPL	2003-05-13
38945	SUPPL	2002-09-25
30039	SUPPL	2002-09-25
30038	SUPPL	2002-09-25
17838	SUPPL	2002-09-25