Application 213768

Type: ANDA
Sponsor: GUANGDONG SUNHO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	20MG/ML (20MG/ML)	No	No
002	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	80MG/4ML (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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213768-001	DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP		2025-05-13
A213768-002	DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP		2025-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213768-001	AP
A213768-002	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.

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	A213768-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2025-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213768-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2025-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213768-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2025-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213768-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2025-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213768-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2025-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213768-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2025-05-13	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213768-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2025-05-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213768-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2025-05-13	`a50c72e98297…`

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	A213768-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213768-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213768-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213768-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213768-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213768-002	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213768-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213768-002	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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Docetaxel	DOCETAXEL	Meitheal Pharmaceuticals Inc.	f970e352-3d43-4cc4-a859-503ec37b6e22	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213768 application number: ANDA213768