Application 204957

Type: NDA
Sponsor: B BRAUN MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	ACETAMINOPHEN	SOLUTION;INTRAVENOUS	1GM/100ML?(10MG/ML)	No	No
002	ACETAMINOPHEN	ACETAMINOPHEN	SOLUTION;INTRAVENOUS	500MG/50ML?(10MG/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
N204957-001	ACETAMINOPHEN	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-02-18
N204957-002	ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2021-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204957-001	AP
N204957-002	AP2

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 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2021-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2021-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2021-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-18	`87673890dc5c…`

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	N204957-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204957-002	AP2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204957-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204957-002	AP2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204957-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204957-002	AP2	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204957-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204957-002	AP2	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	ProPharma Distribution	3f7a6fdc-6e36-dc3e-e063-6394a90a067d	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204957 application number: NDA204957
Acetaminophen	ACETAMINOPHEN	B. Braun Medical Inc.	9744d804-2857-47ef-a27a-bca27db9394c	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204957 application number: NDA204957 ndc (product): 0264-4050
Acetaminophen	ACETAMINOPHEN	B. Braun Medical Inc.	6d763554-913d-4bed-9efd-b9c9b936a2f4	2023-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204957 application number: NDA204957 ndc (product): 0264-4050 ndc (product): 0264-4100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-4050	Acetaminophen	Acetaminophen	B. Braun Medical Inc.	NDA	Current
0264-4050	Acetaminophen	Acetaminophen	B. Braun Medical Inc.	NDA	Current
0264-4050	Acetaminophen	Acetaminophen	B. Braun Medical Inc.	NDA	Current
0264-4050	Acetaminophen	Acetaminophen	B. Braun Medical Inc.	NDA	Current
0264-4100	Acetaminophen	Acetaminophen	B. Braun Medical Inc.	NDA	Current
0264-4100	Acetaminophen	Acetaminophen	B. Braun Medical Inc.	NDA	Current
0264-4100	Acetaminophen	Acetaminophen	B. Braun Medical Inc.	NDA	Current
0264-4100	Acetaminophen	Acetaminophen	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68511	ORIG	2021-09-01
66301	ORIG	2021-02-22
66302	ORIG	2021-02-19