Application 205720

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PACLITAXEL	PACLITAXEL	INJECTABLE;INJECTION	6MG/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205720-001	PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP		2018-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205720-001	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 2 · 41 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	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION		2018-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION		2018-08-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION		2018-08-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION		2018-08-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION		2018-08-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION		2018-08-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION		2018-08-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION		2018-08-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205720-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2018-08-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205720-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205720-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205720-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205720-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205720-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205720-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205720-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205720-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205720-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205720-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205720-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205720-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205720-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205720-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205720-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205720-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205720-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205720-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205720-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205720-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205720-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205720-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205720-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205720-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205720-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205720-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205720-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205720-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205720-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205720-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205720-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205720-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205720-001	AP	1	`a50c72e98297…`

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 · 24 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 brand name: Paclitaxel generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Teva Parenteral Medicines, Inc.	e4be6cbf-72b9-4f7f-9b1b-459b2d35961a	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Hospira, Inc.	ea28753a-8631-460a-bfdc-b101eb8ac84a	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	BluePoint Laboratories	59906bd2-8337-4cd8-9288-65b90eac2a7a	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel generic name: PACLITAXEL
PACLITAXEL	PACLITAXEL	Mylan Institutional LLC	a1a06de1-d9a4-460a-b87d-5e40305b065c	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PACLITAXEL generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Bryant Ranch Prepack	30384708-1fcd-4a75-94d7-9d5d617a37b6	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel generic name: PACLITAXEL
Paclitaxel	PACLITAXEL (AIBUMIN-BOUND)	Ningbo Shuangcheng Pharmaceutical Co., Ltd	4df3fda6-0b29-420e-ab91-81441ce914ed	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel
Paclitaxel	PACLITAXEL	Natco Pharma USA LLC	a1eb16b4-285b-4e81-9c4e-1244d4a52af8	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel 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 brand name: Paclitaxel generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Sandoz Inc	15ca4829-8fee-45f9-b4bc-b31c15732cd6	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel 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 brand name: Paclitaxel generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Alembic Pharmaceuticals Inc.	0c12c77c-5fd4-48dc-a318-e96892233992	2024-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Sagent Pharmaceuticals	5721b9bf-c3c1-4b73-b96c-5fbe3147b6a5	2024-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Teva Pharmaceuticals, Inc.	15dd51ed-29e8-468b-b6d1-21b1f84d6f2e	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel 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 brand name: Paclitaxel generic name: PACLITAXEL

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-098	Paclitaxel	PACLITAXEL	Accord Healthcare, Inc.	ANDA	Current