Application 091112

Type: ANDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMINO ACIDS	AMINO ACIDS	INJECTABLE;INJECTION	15%(150GM/1000ML)	No	No
002	AMINO ACIDS	AMINO ACIDS	INJECTABLE;INJECTION	15%(300GM/2000ML)	No	No

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
A091112-001	AMINO ACIDS	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION			2012-04-13
A091112-002	AMINO ACIDS	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION			2012-04-13

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091112-001	AMINO ACIDS	15%(150GM/1000ML)	INJECTABLE / INJECTION	2012-04-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091112-002	AMINO ACIDS	15%(300GM/2000ML)	INJECTABLE / INJECTION	2012-04-13	`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
Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINE	B. Braun Medical Inc.	a3244d1a-45b0-4e4c-bd96-f0632d761a1f	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091112 application number: ANDA091112 ndc (product): 0264-4500

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-3200	Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE	B. Braun Medical Inc.	ANDA	Current
0264-3200	Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE	B. Braun Medical Inc.	ANDA	Current
0264-3205	Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE	B. Braun Medical Inc.	ANDA	Current
0264-3205	Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE	B. Braun Medical Inc.	ANDA	Current
0264-4500	Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE	B. Braun Medical Inc.	ANDA	Current
0264-4500	Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE	B. Braun Medical Inc.	ANDA	Current
0264-4500	Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE	B. Braun Medical Inc.	ANDA	Current