Application 201525

Type: NDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	20MG/2ML (10MG/ML)	No	No
002	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	80MG/8ML (10MG/ML)	No	No
003	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	160MG/16ML (10MG/ML)	No	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	Approval date
N201525-001	DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29
N201525-002	DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29
N201525-003	DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N201525-001	AP
N201525-002	AP
N201525-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N201525-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201525-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201525-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201525-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201525-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201525-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201525-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201525-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201525-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201525-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201525-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201525-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201525-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201525-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201525-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201525-001	AP	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Docetaxel	DOCETAXEL	Baxter Healthcare Corporation	0e0f06bd-d190-45da-be8b-062e8de01970	2023-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201525 application number: NDA201525 ndc (product): 43066-010 ndc (product): 43066-001 ndc (product): 43066-006
Docetaxel	DOCETAXEL	Sandoz Inc.	e03d1378-6889-43d5-a34c-f96132cffa88	2023-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201525 application number: NDA201525 ndc (product): 66758-050

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75561	SUPPL	2023-09-25
75533	SUPPL	2023-09-22
65904	SUPPL	2021-01-14
65902	SUPPL	2021-01-14
64267	SUPPL	2020-08-12
64266	SUPPL	2020-08-12
61530	SUPPL	2020-01-07
61514	SUPPL	2020-01-06
59615	SUPPL	2019-08-07
58137	SUPPL	2019-03-29
58136	SUPPL	2019-03-29
58134	SUPPL	2019-03-28
58133	SUPPL	2019-03-28
45636	SUPPL	2016-10-25
19023	SUPPL	2014-11-07
19022	SUPPL	2014-11-07
32115	SUPPL	2014-11-05
9902	SUPPL	2014-11-05
19021	SUPPL	2014-04-25
9901	SUPPL	2014-04-24
9900	SUPPL	2012-03-19
19020	SUPPL	2012-03-16
43368	ORIG	2012-01-12
24395	ORIG	2012-01-12
9899	ORIG	2011-07-06
19019	ORIG	2011-06-30