Orange Book product · Generic (ANDA)
AMINO ACIDS
AMINO ACIDS
At a glance
Apr 13, 2012
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 13, 2012
14 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
AMINO ACIDS
Strength
15%(150GM/1000ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 091112
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMINO ACIDS
- 1998PROSOL 20% SULFITE FREE IN PLASTIC CONTAINERBrand (NDA)
NDA 020849 · BAXTER HLTHCARE
- 1993NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINERBrand (NDA)
NDA 020107 · BAXTER HLTHCARE
- 1991AMINOSYN II 10% IN PLASTIC CONTAINERBrand (NDA)
NDA 020015 · OTSUKA ICU MEDCL
- 1991AMINOSYN II 15% IN PLASTIC CONTAINERBrand (NDA)
NDA 020041 · OTSUKA ICU MEDCL
- 1986AMINOSYN-PF 10%Brand (NDA)
NDA 019492 · OTSUKA ICU MEDCL
- 1986AMINOSYN II 3.5% IN PLASTIC CONTAINERBrand (NDA)
NDA 019491 · ABBOTT
- 1986AMINOSYN-HBC 7% IN PLASTIC CONTAINERBrand (NDA)
NDA 019400 · ABBOTT
- 1986AMINOSYN II 10%Brand (NDA)
NDA 019438 · ICU MEDICAL INC
- 1985AMINOSYN-PF 7%Brand (NDA)
NDA 019398 · OTSUKA ICU MEDCL
- 1985AMINOSYN-HBC 7%Brand (NDA)
NDA 019374 · ICU MEDICAL INC
- 1984BRANCHAMIN 4%Brand (NDA)
NDA 018678 · BAXTER HLTHCARE
- 1984BRANCHAMIN 4% IN PLASTIC CONTAINERBrand (NDA)
NDA 018684 · BAXTER HLTHCARE
Listed patents
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.
