Application 020262

Type: NDA
Sponsor: HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAXOL	PACLITAXEL	INJECTABLE;INJECTION	6MG/ML	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020262-001	TAXOL	PACLITAXEL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29

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 2 · 41 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UTC	2026-02	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020262-001	TAXOL	6MG/ML	INJECTABLE / INJECTION		RLD	1992-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020262-001	TAXOL	6MG/ML	INJECTABLE / INJECTION		RLD	1992-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020262-001	TAXOL	6MG/ML	INJECTABLE / INJECTION		RLD	1992-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020262-001	TAXOL	6MG/ML	INJECTABLE / INJECTION		RLD	1992-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020262-001	TAXOL	6MG/ML	INJECTABLE / INJECTION		RLD	1992-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020262-001	TAXOL	6MG/ML	INJECTABLE / INJECTION		RLD	1992-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020262-001	TAXOL	6MG/ML	INJECTABLE / INJECTION		RLD	1992-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020262-001	TAXOL	6MG/ML	INJECTABLE / INJECTION		RLD	1992-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020262-001	TAXOL	6MG/ML	INJECTABLE / INJECTION		RLD	1992-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020262-001	TAXOL	6MG/ML	INJECTABLE / INJECTION		RLD	1992-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	AP	RLD	1992-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	AP	RLD	1992-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020262-001	TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-12-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	N020262-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020262-001	AP	1	`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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paclitaxel	PACLITAXEL	Teva Parenteral Medicines, Inc.	fbd32bd2-9685-41cb-bee2-730a45526b65	2026-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Teva Parenteral Medicines, Inc.	e4be6cbf-72b9-4f7f-9b1b-459b2d35961a	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Hospira, Inc.	ea28753a-8631-460a-bfdc-b101eb8ac84a	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	BluePoint Laboratories	59906bd2-8337-4cd8-9288-65b90eac2a7a	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
PACLITAXEL	PACLITAXEL	Mylan Institutional LLC	a1a06de1-d9a4-460a-b87d-5e40305b065c	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Bryant Ranch Prepack	30384708-1fcd-4a75-94d7-9d5d617a37b6	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Natco Pharma USA LLC	a1eb16b4-285b-4e81-9c4e-1244d4a52af8	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
PACLITAXEL PACLITAXEL	PACLITAXEL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b4c5d08a-e0f5-4af1-97d6-213705adedf1	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	PACLITAXEL	NorthStar Rx LLC	1e9d5093-fbfc-470a-8520-811c46a8870c	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	PACLITAXEL	BluePoint Laboratories	36d4a2ed-4b34-4b06-e063-6394a90acc86	2025-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	BluePoint Laboratories	9e7bc2c2-a369-4c6f-9dd9-ee98ddaae833	2025-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Sandoz Inc	15ca4829-8fee-45f9-b4bc-b31c15732cd6	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	PACLITAXEL	Meitheal Pharmaceuticals Inc.	31e893aa-8d9e-4576-8614-eb2fe772bde4	2025-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Fresenius Kabi USA, LLC	a6c24189-293f-42ca-b969-75870bb55af0	2024-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Alembic Pharmaceuticals Inc.	0c12c77c-5fd4-48dc-a318-e96892233992	2024-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Sagent Pharmaceuticals	5721b9bf-c3c1-4b73-b96c-5fbe3147b6a5	2024-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Teva Pharmaceuticals, Inc.	15dd51ed-29e8-468b-b6d1-21b1f84d6f2e	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND	PACLITAXEL	American Regent, Inc.	f06d1bb3-83f1-4d84-8004-4c6681ad8a5a	2023-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Alembic Pharmaceuticals Limited	6d04b514-c85c-4db1-919e-21dd98172791	2023-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
ABRAXANE	PACLITAXEL	Abraxis BioScience, LLC	24d10449-2936-4cd3-b7db-a7683db721e4	2022-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-504	Paclitaxel	Paclitaxel	WG Critical Care, LLC	NDA	Current
44567-504	Paclitaxel	Paclitaxel	WG Critical Care, LLC	NDA	Current
44567-504	Paclitaxel	Paclitaxel	WG Critical Care, LLC	NDA	Current
44567-505	Paclitaxel	Paclitaxel	WG Critical Care, LLC	NDA	Current
44567-505	Paclitaxel	Paclitaxel	WG Critical Care, LLC	NDA	Current
44567-505	Paclitaxel	Paclitaxel	WG Critical Care, LLC	NDA	Current
44567-506	Paclitaxel	Paclitaxel	WG Critical Care, LLC	NDA	Current
44567-506	Paclitaxel	Paclitaxel	WG Critical Care, LLC	NDA	Current
44567-506	Paclitaxel	Paclitaxel	WG Critical Care, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53723	SUPPL	2018-04-18
12391	SUPPL	2015-03-05
24685	SUPPL	2015-03-04
24684	SUPPL	2011-05-04
34447	SUPPL	2011-05-02
24683	SUPPL	2010-09-07
12390	SUPPL	2010-08-28
41250	SUPPL	2005-12-16
41249	SUPPL	2005-12-16
20575	SUPPL	2005-12-16
2264	SUPPL	2003-03-26
24679	SUPPL	2002-08-29
24682	SUPPL	2002-03-04
24681	SUPPL	2002-03-04
41248	SUPPL	2000-07-06
34446	SUPPL	2000-06-20
24680	SUPPL	2000-06-20
41247	SUPPL	2000-06-15
41246	SUPPL	2000-06-15
20574	SUPPL	2000-06-15
24678	SUPPL	1999-10-25
12389	SUPPL	1999-10-25
41245	SUPPL	1999-09-09
41244	SUPPL	1999-01-08
41243	SUPPL	1999-01-08
20573	SUPPL	1999-01-08
24675	SUPPL	1998-06-30
12386	SUPPL	1998-06-30
34445	SUPPL	1998-04-09
24677	SUPPL	1998-04-09
24676	SUPPL	1998-04-09
12388	SUPPL	1998-04-09
12387	SUPPL	1998-04-09
2263	SUPPL	1998-04-09