Application 019018

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TROPHAMINE	AMINO ACIDS	INJECTABLE;INJECTION	6% (6GM/100ML)	Yes	Yes
003	TROPHAMINE 10%	AMINO ACIDS	INJECTABLE;INJECTION	10% (10GM/100ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019018-001	TROPHAMINE	AMINO ACIDS	6% (6GM/100ML)	INJECTABLE / INJECTION		RLD, RS	1984-07-20
N019018-003	TROPHAMINE 10%	AMINO ACIDS	10% (10GM/100ML)	INJECTABLE / INJECTION		RLD, RS	1988-09-07

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019018-001	TROPHAMINE	6% (6GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019018-003	TROPHAMINE 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	RLD, RS	1988-09-07	`bb7c543d1eb4…`

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
TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINE	B. Braun Medical Inc.	cb6d23ff-3ec5-445a-acbe-f88fd57949bf	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019018 application number: NDA019018 ndc (product): 0264-1933

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-1933	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current
0264-1933	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current
0264-1933	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current
0264-9341	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current
0264-9341	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current
0264-9341	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current
0264-9341	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current
0264-9361	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current
0264-9361	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current
0264-9361	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current
0264-9361	TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65301	SUPPL	2020-11-23
65226	SUPPL	2020-11-16
11415	SUPPL	2004-04-05
16175	SUPPL	2004-03-28