Application 016822

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FREAMINE 8.5%	AMINO ACIDS	INJECTABLE;INJECTION	8.5% (8.5GM/100ML)	No	No
002	FREAMINE II 8.5%	AMINO ACIDS	INJECTABLE;INJECTION	8.5% (8.5GM/100ML)	No	No
003	FREAMINE III 3% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML	No	No
004	FREAMINE III 8.5%	AMINO ACIDS	INJECTABLE;INJECTION	8.5% (8.5GM/100ML)	No	No
005	FREAMINE III 10%	AMINO ACIDS	INJECTABLE;INJECTION	10% (10GM/100ML)	No	No
006	FREAMINE HBC 6.9%	AMINO ACIDS	INJECTABLE;INJECTION	6.9% (6.9GM/100ML)	No	No
007	FREAMINE III 8.5% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE	INJECTABLE;INJECTION	8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N016822-001	FREAMINE 8.5%	AMINO ACIDS	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982
N016822-002	FREAMINE II 8.5%	AMINO ACIDS	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982
N016822-003	FREAMINE III 3% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N016822-004	FREAMINE III 8.5%	AMINO ACIDS	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982
N016822-005	FREAMINE III 10%	AMINO ACIDS	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982
N016822-006	FREAMINE HBC 6.9%	AMINO ACIDS	6.9% (6.9GM/100ML)	INJECTABLE / INJECTION		1983-05-17
N016822-007	FREAMINE III 8.5% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE	8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML	INJECTABLE / INJECTION		1988-07-01

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 8 of 8 · 308 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N016822-001	FREAMINE 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N016822-002	FREAMINE II 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N016822-003	FREAMINE III 3% W/ ELECTROLYTES	3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N016822-004	FREAMINE III 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N016822-005	FREAMINE III 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N016822-006	FREAMINE HBC 6.9%	6.9% (6.9GM/100ML)	INJECTABLE / INJECTION		1983-05-17	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N016822-007	FREAMINE III 8.5% W/ ELECTROLYTES	8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML	INJECTABLE / INJECTION		1988-07-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016822-001	FREAMINE 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N016822-002	FREAMINE II 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N016822-003	FREAMINE III 3% W/ ELECTROLYTES	3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N016822-004	FREAMINE III 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N016822-005	FREAMINE III 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N016822-006	FREAMINE HBC 6.9%	6.9% (6.9GM/100ML)	INJECTABLE / INJECTION		1983-05-17	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N016822-007	FREAMINE III 8.5% W/ ELECTROLYTES	8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML	INJECTABLE / INJECTION		1988-07-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016822-001	FREAMINE 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016822-002	FREAMINE II 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016822-003	FREAMINE III 3% W/ ELECTROLYTES	3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016822-004	FREAMINE III 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016822-005	FREAMINE III 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016822-006	FREAMINE HBC 6.9%	6.9% (6.9GM/100ML)	INJECTABLE / INJECTION		1983-05-17	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016822-007	FREAMINE III 8.5% W/ ELECTROLYTES	8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML	INJECTABLE / INJECTION		1988-07-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016822-001	FREAMINE 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016822-002	FREAMINE II 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016822-003	FREAMINE III 3% W/ ELECTROLYTES	3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML	INJECTABLE / INJECTION	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016822-004	FREAMINE III 8.5%	8.5% (8.5GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016822-005	FREAMINE III 10%	10% (10GM/100ML)	INJECTABLE / INJECTION	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016822-006	FREAMINE HBC 6.9%	6.9% (6.9GM/100ML)	INJECTABLE / INJECTION		1983-05-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016822-007	FREAMINE III 8.5% W/ ELECTROLYTES	8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML	INJECTABLE / INJECTION		1988-07-01	`a50c72e98297…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-9010	FreAmine III	ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, PHOSPHORIC ACID, and SODIUM BISULFITE	B. Braun Medical Inc.	NDA	Current
0264-9010	FreAmine III	ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, PHOSPHORIC ACID, and SODIUM BISULFITE	B. Braun Medical Inc.	NDA	Current
0264-9010	FreAmine III	ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, PHOSPHORIC ACID, and SODIUM BISULFITE	B. Braun Medical Inc.	NDA	Current
0264-9350	FreAmine HBC	ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, and SODIUM BISULFITE	B. Braun Medical Inc.	NDA	Current
0264-9350	FreAmine HBC	ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, and SODIUM BISULFITE	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33200	SUPPL	2004-06-01
13038	SUPPL	2004-06-01