Application 216081

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	18.1416GM/30ML (604.72MG/ML)	No	No
002	GADOBUTROL	GADOBUTROL	SOLUTION;INTRAVENOUS	39.3068GM/65ML (604.72MG/ML)	No	No
003	GADOBUTROL	GADOBUTROL	SOLUTION;INTRAVENOUS	1.20944GM/2ML (604.72MG/ML)	No	No
004	GADOBUTROL	GADOBUTROL	SOLUTION;INTRAVENOUS	4.5354GM/7.5ML (604.72MG/ML)	No	No
005	GADOBUTROL	GADOBUTROL	SOLUTION;INTRAVENOUS	6.0472GM/10ML (604.72MG/ML)	No	No
006	GADOBUTROL	GADOBUTROL	SOLUTION;INTRAVENOUS	9.0708GM/15ML (604.72MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A216081-001	GADOBUTROL	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08
A216081-002	GADOBUTROL	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08
A216081-003	GADOBUTROL	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17
A216081-004	GADOBUTROL	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17
A216081-005	GADOBUTROL	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17
A216081-006	GADOBUTROL	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216081-001	AP
A216081-002	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.

Product history page 1 of 3 · 106 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
2026-10-15 13:18:30	2026-09	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS		2022-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-005	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-006	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-001	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-002	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2023-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-003	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-004	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-17	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A216081-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216081-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A216081-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216081-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216081-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216081-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216081-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216081-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216081-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216081-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216081-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216081-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216081-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-004	AP	1	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-001	CGT	2024-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216081-002	CGT	2024-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-001	CGT	2024-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216081-002	CGT	2024-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216081-001	CGT	2024-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216081-002	CGT	2024-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216081-001	CGT	2024-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216081-002	CGT	2024-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216081-001	CGT	2024-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216081-002	CGT	2024-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216081-001	CGT	2024-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216081-002	CGT	2024-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216081-001	CGT	2024-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216081-002	CGT	2024-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216081-001	CGT	2024-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216081-002	CGT	2024-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216081-001	CGT	2024-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216081-002	CGT	2024-04-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216081-001	CGT	2024-04-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216081-002	CGT	2024-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216081-001	CGT	2024-04-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216081-002	CGT	2024-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216081-001	CGT	2024-04-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216081-002	CGT	2024-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216081-001	CGT	2024-04-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216081-002	CGT	2024-04-29	`a72a2bbeb626…`

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	c0dd1618-0bb3-4974-846b-e5afc2311ae6	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216081 application number: ANDA216081

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75953	ORIG	2023-10-27