Application 050629

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	2MG/ML	Yes	Yes
002	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	200MG/100ML	Yes	Yes
003	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	150MG/75ML	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050629-001	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23
N050629-002	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03
N050629-003	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050629-001	AP
N050629-002	AP

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050629-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050629-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050629-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050629-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050629-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050629-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050629-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050629-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050629-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050629-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050629-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050629-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050629-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050629-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050629-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050629-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050629-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050629-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050629-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050629-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050629-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050629-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050629-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050629-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050629-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050629-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050629-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050629-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050629-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050629-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050629-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050629-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050629-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050629-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050629-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050629-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050629-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050629-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050629-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050629-002	AP	1	`782e0a99824c…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Pfizer Laboratories Div Pfizer Inc	1fd148fb-0fbc-4b6f-b790-23546fb46a71	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050629 application number: NDA050629 ndc (product): 0069-3030 ndc (product): 0069-3032 ndc (product): 0069-3031 ndc (product): 0069-3034 ndc (product): 0069-3033
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Pfizer Laboratories Div Pfizer Inc	00634b2b-4e48-4178-8877-28582af894ad	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050629 application number: NDA050629 ndc (product): 0069-4004 ndc (product): 0069-4026 ndc (product): 0069-4015
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Pfizer Laboratories Div Pfizer Inc	d31d7f58-66d0-4826-b6b5-5914c031965f	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050629 application number: NDA050629 ndc (product): 0069-4031

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 101 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-3030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3033	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3033	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3033	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3033	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3033	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3033	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3033	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3034	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3034	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3034	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3034	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3034	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3034	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3034	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4004	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4004	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4004	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4004	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4004	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4004	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4015	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4015	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4015	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4015	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4015	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4015	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4026	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4026	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4026	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4026	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4026	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4026	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-4033	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78470	SUPPL	2024-05-15
78469	SUPPL	2024-05-15
65072	SUPPL	2020-10-29
64453	SUPPL	2020-08-31
61441	SUPPL	2019-12-26
61393	SUPPL	2019-12-23
59677	SUPPL	2019-08-12
59661	SUPPL	2019-08-12
7906	SUPPL	2013-11-06
17954	SUPPL	2013-11-01
7905	SUPPL	2011-09-29
17953	SUPPL	2011-09-26
7904	SUPPL	2010-08-09
17952	SUPPL	2010-07-30
30189	SUPPL	2003-05-30
7903	SUPPL	2003-05-30
17951	SUPPL	2003-05-29
17950	SUPPL	2003-05-13
39053	SUPPL	2002-09-25
17949	SUPPL	2002-09-25
7902	SUPPL	2002-09-25
7901	SUPPL	2002-09-25