Application 215061

Type: ANDA
Sponsor: HENGRUI PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GADOBUTROL	GADOBUTROL	SOLUTION;INTRAVENOUS	1.20944GM/2ML (604.72MG/ML)	No	No
002	GADOBUTROL	GADOBUTROL	SOLUTION;INTRAVENOUS	4.5354GM/7.5ML (604.72MG/ML)	No	No
003	GADOBUTROL	GADOBUTROL	SOLUTION;INTRAVENOUS	6.0472GM/10ML (604.72MG/ML)	No	No
004	GADOBUTROL	GADOBUTROL	SOLUTION;INTRAVENOUS	9.0708GM/15ML (604.72MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 · 48 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
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215061-001	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215061-002	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215061-003	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215061-004	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215061-001	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215061-002	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215061-003	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215061-004	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215061-001	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215061-002	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215061-003	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215061-004	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215061-001	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215061-002	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215061-003	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215061-004	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215061-001	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215061-002	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215061-003	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215061-004	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215061-001	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215061-002	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215061-003	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215061-004	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215061-001	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215061-002	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215061-003	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215061-004	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215061-001	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215061-002	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215061-003	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215061-004	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215061-001	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215061-002	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215061-003	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215061-004	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215061-001	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215061-002	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215061-003	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215061-004	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`3f0d92c62455…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215061-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215061-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215061-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215061-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215061-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215061-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215061-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215061-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215061-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215061-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215061-003	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215061-004	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215061-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215061-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215061-003	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215061-004	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215061-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215061-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215061-003	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215061-004	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215061-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215061-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215061-003	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215061-004	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215061-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215061-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215061-003	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215061-004	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215061-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215061-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215061-003	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215061-004	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215061-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215061-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215061-003	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215061-004	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215061-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215061-002	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215061-003	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215061-004	AP	1	`3f0d92c62455…`

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
Gadobutrol	GADOBUTROL	Fresenius Kabi USA, LLC	007696d0-4b62-4937-9640-4ad619504df4	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215061 application number: ANDA215061

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72940	ORIG	2022-12-20