Application 022534

Type: NDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOCEFREZ	DOCETAXEL	INJECTABLE;INJECTION	20MG/VIAL	Yes	No
002	DOCEFREZ	DOCETAXEL	INJECTABLE;INJECTION	80MG/VIAL	Yes	No
003	DOCETAXEL	DOCETAXEL	SOLUTION;INTRAVENOUS	20MG/ML (20MG/ML)	No	No
004	DOCETAXEL	DOCETAXEL	SOLUTION;INTRAVENOUS	80MG/4ML (20MG/ML)	No	No
005	DOCETAXEL	DOCETAXEL	SOLUTION;INTRAVENOUS	160MG/8ML (20MG/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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022534-001	DOCEFREZ	DOCETAXEL	20MG/VIAL	INJECTABLE / INJECTION	RLD	2011-05-03
N022534-002	DOCEFREZ	DOCETAXEL	80MG/VIAL	INJECTABLE / INJECTION	RLD	2011-05-03
N022534-003	DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION		2019-01-08
N022534-004	DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION		2019-01-08
N022534-005	DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION		2019-01-08

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 6 · 205 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	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022534-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022534-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022534-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022534-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022534-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022534-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022534-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022534-004	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022534-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022534-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022534-004	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022534-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022534-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022534-004	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022534-005	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022534-003	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022534-004	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022534-005	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022534-003	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022534-004	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022534-005	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022534-003	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022534-004	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022534-005	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022534-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022534-004	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022534-005	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022534-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022534-004	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022534-005	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022534-003	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022534-004	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022534-005	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022534-003	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Docetaxel	DOCETAXEL	Sun Pharmaceutical Industries, Inc.	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	2021-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022534 application number: NDA022534 ndc (product): 47335-323 ndc (product): 47335-895 ndc (product): 47335-939

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-323	Docetaxel	Docetaxel	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-323	Docetaxel	Docetaxel	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-895	Docetaxel	Docetaxel	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-895	Docetaxel	Docetaxel	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-939	Docetaxel	Docetaxel	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-939	Docetaxel	Docetaxel	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75280	SUPPL	2023-08-24
75267	SUPPL	2023-08-23
72862	SUPPL	2022-12-12
72860	SUPPL	2022-12-12
66099	SUPPL	2021-02-05
66070	SUPPL	2021-02-03
61973	SUPPL	2020-02-26
61962	SUPPL	2020-02-26
57262	SUPPL	2019-01-18
57157	SUPPL	2019-01-09
38823	SUPPL	2014-11-04
29841	SUPPL	2014-10-31
38822	SUPPL	2012-07-25
7512	SUPPL	2012-07-20
24334	ORIG	2012-02-10
22049	ORIG	2012-02-10
17689	ORIG	2011-05-24
29840	ORIG	2011-05-05
7511	ORIG	2010-03-22