Application 201277

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GADAVIST	GADOBUTROL	SOLUTION;INTRAVENOUS	4.5354GM/7.5ML (604.72MG/ML)	Yes	Yes
002	GADAVIST	GADOBUTROL	SOLUTION;INTRAVENOUS	6.0472GM/10ML (604.72MG/ML)	Yes	Yes
003	GADAVIST	GADOBUTROL	SOLUTION;INTRAVENOUS	9.0708GM/15ML (604.72MG/ML)	Yes	Yes
004	GADAVIST	GADOBUTROL	SOLUTION;INTRAVENOUS	18.1416GM/30ML (604.72MG/ML)	Yes	Yes
005	GADAVIST	GADOBUTROL	SOLUTION;INTRAVENOUS	39.3068GM/65ML (604.72MG/ML)	Yes	Yes
006	GADAVIST	GADOBUTROL	SOLUTION;INTRAVENOUS	1.20944GM/2ML (604.72MG/ML)	Yes	Yes

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	RLD / RS	Approval date
N201277-001	GADAVIST	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14
N201277-002	GADAVIST	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14
N201277-003	GADAVIST	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14
N201277-004	GADAVIST	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14
N201277-005	GADAVIST	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2011-03-14
N201277-006	GADAVIST	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-12-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N201277-001	AP
N201277-002	AP
N201277-003	AP
N201277-004	AP
N201277-005	AP
N201277-006	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 4 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201277-005	GADAVIST	39.3068GM/65ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201277-006	GADAVIST	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201277-001	GADAVIST	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201277-002	GADAVIST	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201277-003	GADAVIST	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201277-004	GADAVIST	18.1416GM/30ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2011-03-14	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 154 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	N201277-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201277-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201277-003	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201277-004	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201277-005	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201277-006	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N201277-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201277-006	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201277-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201277-006	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201277-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201277-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201277-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201277-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201277-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201277-004	AP	1	`fd3edfee7708…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201277-006	5980864	2021-11-09	U-1119	Drug substance, Drug product	2016-03-17	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-001	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-002	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-003	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-004	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-005	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201277-006	I-801	2022-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201277-001	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201277-002	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201277-003	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201277-004	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201277-005	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201277-006	I-801	2022-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201277-001	I-801	2022-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201277-002	I-801	2022-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201277-003	I-801	2022-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201277-004	I-801	2022-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201277-005	I-801	2022-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201277-006	I-801	2022-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201277-001	I-801	2022-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-002	I-731	2019-04-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-002	I-801	2022-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-003	I-801	2022-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-004	I-801	2022-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-005	I-801	2022-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201277-006	I-801	2022-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201277-001	I-801	2022-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-002	I-801	2022-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-003	I-801	2022-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-004	I-801	2022-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-005	I-801	2022-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201277-006	I-801	2022-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201277-001	I-801	2022-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-002	I-801	2022-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-003	I-801	2022-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-004	I-801	2022-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-005	I-801	2022-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201277-006	I-801	2022-07-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-001	I-801	2022-07-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-002	I-801	2022-07-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201277-003	I-801	2022-07-12	`87673890dc5c…`

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
Gadavist	GADOBUTROL	Bayer HealthCare Pharmaceuticals Inc.	bd28560f-de4d-4140-874e-31df823f4dbb	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201277 application number: NDA201277 ndc (product): 50419-325

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-325	Gadavist	gadobutrol	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85094	SUPPL	2026-03-23
85095	SUPPL	2026-02-20
85050	SUPPL	2026-02-18
81494	SUPPL	2025-03-07
81453	SUPPL	2025-03-06
79196	SUPPL	2024-07-24
79180	SUPPL	2024-07-24
77345	SUPPL	2024-01-29
77338	SUPPL	2024-01-29
71104	SUPPL	2022-05-20
71103	SUPPL	2022-05-20
64182	SUPPL	2020-08-03
64181	SUPPL	2020-08-03
64152	SUPPL	2020-07-31
59332	SUPPL	2019-07-15
59325	SUPPL	2019-07-12
59324	SUPPL	2019-07-12
56456	SUPPL	2018-11-15
56305	SUPPL	2018-11-06
55038	SUPPL	2018-07-30
55023	SUPPL	2018-07-27
55022	SUPPL	2018-07-27
53909	SUPPL	2018-05-01
53854	SUPPL	2018-04-27
18998	SUPPL	2016-05-05
9874	SUPPL	2016-04-28
18997	SUPPL	2015-09-21
9873	SUPPL	2015-08-03
40057	SUPPL	2015-01-05
9872	SUPPL	2014-12-31
9871	SUPPL	2014-06-12
40056	SUPPL	2013-10-21
32090	SUPPL	2013-10-18
9870	SUPPL	2012-03-26
44833	ORIG	2011-04-11
22848	ORIG	2011-04-11
32089	ORIG	2011-03-16
40055	ORIG	2011-03-15
66905	ORIG	1900-01-01
66904	ORIG	1900-01-01
66903	ORIG	1900-01-01
54108	ORIG	1900-01-01
54107	ORIG	1900-01-01
51135	SUPPL	1900-01-01
51134	SUPPL	1900-01-01
51133	SUPPL	1900-01-01