Is there a generic for Amino acids?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Amino acids, referencing the brand PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Amino acids?

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER (NDA 020849, BAXTER HLTHCARE) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Amino acids are approved?

Amino acids is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Amino acids

Amino acids: 26 brands, 5 generics; first approved Aug 03, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 5 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINERRLDRS
BAXTER HLTHCARENDA 0208491998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% (20GM/100ML) INJECTABLE INJECTION Rx —
TROPHAMINERLDRS
B BRAUNNDA 01901819842 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6% (6GM/100ML) INJECTABLE INJECTION Rx —
10% (10GM/100ML) INJECTABLE INJECTION Rx —
NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER
BAXTER HLTHCARENDA 0201071993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15% (15GM/100ML) INJECTABLE INJECTION Discontinued —
AMINOSYN II 10% IN PLASTIC CONTAINER
OTSUKA ICU MEDCLNDA 0200151991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% (10GM/100ML) INJECTABLE INJECTION Rx —
AMINOSYN II 15% IN PLASTIC CONTAINER
OTSUKA ICU MEDCLNDA 0200411991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15% (15GM/100ML) INJECTABLE INJECTION Rx —
AMINOSYN-PF 10%
OTSUKA ICU MEDCLNDA 0194921986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% (10GM/100ML) INJECTABLE INJECTION Rx —
AMINOSYN II 3.5% IN PLASTIC CONTAINER
ABBOTTNDA 0194911986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3.5% (3.5GM/100ML) INJECTABLE INJECTION Discontinued —
AMINOSYN-HBC 7% IN PLASTIC CONTAINER
ABBOTTNDA 0194001986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7% (7GM/100ML) INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20% (20GM/100ML)	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6% (6GM/100ML)	INJECTABLE	INJECTION	Rx	—
10% (10GM/100ML)	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15% (15GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10% (10GM/100ML)	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15% (15GM/100ML)	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10% (10GM/100ML)	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7% (7GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

AMINOSYN II 10%

ICU MEDICAL INCNDA 01943819865 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3.5% (3.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
5% (5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
7% (7GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
8.5% (8.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
10% (10GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

AMINOSYN-PF 7%
OTSUKA ICU MEDCLNDA 0193981985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7% (7GM/100ML) INJECTABLE INJECTION Rx —
AMINOSYN-HBC 7%
ICU MEDICAL INCNDA 0193741985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7% (7GM/100ML) INJECTABLE INJECTION Discontinued —
BRANCHAMIN 4%
BAXTER HLTHCARENDA 0186781984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% (4GM/100ML) INJECTABLE INJECTION Discontinued —
BRANCHAMIN 4% IN PLASTIC CONTAINER
BAXTER HLTHCARENDA 0186841984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% (4GM/100ML) INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7% (7GM/100ML)	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7% (7GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4% (4GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4% (4GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

TRAVASOL 10% IN PLASTIC CONTAINER

BAXTER HLTHCARENDA 01893119843 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5.5% (5.5GM/100ML)	INJECTABLE	INJECTION	Rx	—
8.5% (8.5GM/100ML)	INJECTABLE	INJECTION	Rx	—
10% (10MG/100ML)	INJECTABLE	INJECTION	Rx	—

AMINOSYN 3.5% IN PLASTIC CONTAINER
ABBOTTNDA 0188751984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3.5% (3.5GM/100ML) INJECTABLE INJECTION Discontinued —
AMINOSYN 3.5% IN PLASTIC CONTAINER
ABBOTTNDA 0188041984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3.5% (3.5GM/100ML) INJECTABLE INJECTION Discontinued —
AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE
HOSPIRANDA 0189011984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5.2% (5.2GM/100ML) INJECTABLE INJECTION Discontinued —
NEOPHAM 6.4%
HOSPIRANDA 0187921984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6.4% (6.4GM/100ML) INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5.2% (5.2GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6.4% (6.4GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

RENAMIN W/O ELECTROLYTES

BAXTER HLTHCARENDA 01749319824 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5.5% (5.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
8.5% (8.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
10% (10GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
6.5% (6.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

NOVAMINE 11.4%

HOSPIRA INCNDA 01795719823 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8.5% (8.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
11.4% (11.4GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
15% (75GM/500ML)	INJECTABLE	INJECTION	Discontinued	—

HEPATAMINE 8%
B BRAUNNDA 0186761982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% (8GM/100ML) INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8% (8GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

AMINOSYN 10%

ICU MEDICAL INCNDA 017673—7 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5% (5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
7% (7GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
10% (10GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
8.5% (8.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
7% (7GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
8.5% (8.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
10% (10GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

AMINOSYN 3.5%
ICU MEDICAL INCNDA 017789—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3.5% (3.5GM/100ML) INJECTABLE INJECTION Discontinued —
AMINOSYN-RF 5.2%
ICU MEDICAL INCNDA 018429—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5.2% (5.2GM/100ML) INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5.2% (5.2GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

FREAMINE 8.5%

B BRAUNNDA 016822—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8.5% (8.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
8.5% (8.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
8.5% (8.5GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
10% (10GM/100ML)	INJECTABLE	INJECTION	Discontinued	—
6.9% (6.9GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

NEPHRAMINE 5.4%
B BRAUNNDA 017766—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5.4% (5.4GM/100ML) INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5.4% (5.4GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

Generic (ANDA) products (5)

Abbreviated applications

AMINO ACIDS
B BRAUNANDA 09111220122 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15%(150GM/1000ML) INJECTABLE INJECTION Rx —
15%(300GM/2000ML) INJECTABLE INJECTION Rx —
PREMASOL 10% IN PLASTIC CONTAINER
BAXTER HLTHCAREANDA 07588020032 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6% (6GM/100ML) INJECTABLE INJECTION Rx —
10% (10GM/100ML) INJECTABLE INJECTION Rx —
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
BAXTER HLTHCAREANDA 0205121996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15% (15GM/100ML) INJECTABLE INJECTION Rx —
AMINOSYN-HF 8%
ICU MEDICAL INCANDA 0203451996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% (8GM/100ML) INJECTABLE INJECTION Discontinued —
HEPATASOL 8%
BAXTER HLTHCAREANDA 0203601996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% (8GM/100ML) INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15%(150GM/1000ML)	INJECTABLE	INJECTION	Rx	—
15%(300GM/2000ML)	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6% (6GM/100ML)	INJECTABLE	INJECTION	Rx	—
10% (10GM/100ML)	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15% (15GM/100ML)	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8% (8GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8% (8GM/100ML)	INJECTABLE	INJECTION	Discontinued	—

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

First approval

Aug 03, 1982

44 yr 8 mo ago

Most recent approval

Apr 13, 2012

14 yr 7 mo ago

Approvals span 1982–2012 across 31 FDA applications.

Brand (NDA) 2684%

Generic (ANDA) 516%

Amino acids: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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