APPLICATION
NDA017493
TYPE
NDA
ORIGINAL APPROVAL
1976-03-24
LATEST ACTION
2003-04-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TRAVASOL 10% W/O ELECTROLYTESDiscontinued
AMINO ACIDS 10% (10GM/100ML) · INJECTABLE · INJECTION
TRAVASOL 5.5% W/O ELECTROLYTESDiscontinued
AMINO ACIDS 5.5% (5.5GM/100ML) · INJECTABLE · INJECTION
TRAVASOL 8.5% W/ ELECTROLYTESDiscontinued
AMINO ACIDS 8.5%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 522MG/100ML, SODIUM ACETATE 594MG/100ML, SODIUM CHLORIDE 154MG/100ML · INJECTABLE · INJECTION
RENAMIN W/O ELECTROLYTESDiscontinued
AMINO ACIDS 6.5% (6.5GM/100ML) · INJECTABLE · INJECTION
TRAVASOL 8.5% W/O ELECTROLYTESDiscontinued
AMINO ACIDS 8.5% (8.5GM/100ML) · INJECTABLE · INJECTION
TRAVASOL 3.5% W/ ELECTROLYTESDiscontinued
AMINO ACIDS 3.5%, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 131MG/100ML, SODIUM ACETATE 218MG/100ML, SODIUM CHLORIDE 35MG/100ML · INJECTABLE · INJECTION
TRAVASOL 5.5% W/ ELECTROLYTESDiscontinued
AMINO ACIDS 5.5%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 522MG/100ML, SODIUM ACETATE 431MG/100ML, SODIUM CHLORIDE 224MG/100ML · INJECTABLE · INJECTION
Approval history
1999-04-05Manufacturing (CMC) · Supplement 63 · standardAP
1999-03-31Manufacturing (CMC) · Supplement 64 · standardAP
1997-04-30Manufacturing (CMC) · Supplement 52 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 60 · standardAP
1994-05-19Manufacturing (CMC) · Supplement 61 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 62 · standardAP
1993-03-12Labeling · Supplement 56 · standardAP
1993-03-12Labeling · Supplement 53 · standardAP
1992-09-14Manufacturing (CMC) · Supplement 57 · standardAP
1992-08-24Manufacturing (CMC) · Supplement 59 · standardAP
1991-04-03Manufacturing (CMC) · Supplement 58 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 55 · standardAP
1990-05-04Manufacturing (CMC) · Supplement 54 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 51 · standardAP
1987-12-30Manufacturing (CMC) · Supplement 49 · standardAP
1987-11-18Labeling · Supplement 48 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 47 · standardAP
1985-09-20Labeling · Supplement 46 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 41 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 45 · standardAP
1983-01-19Manufacturing (CMC) · Supplement 42 · standardAP
1983-01-19Labeling · Supplement 43 · standardAP
1982-10-15Labeling · Supplement 33 · standardAP
1982-10-15Manufacturing (CMC) · Supplement 32 · standardAP
1982-07-21Manufacturing (CMC) · Supplement 39 · standardAP
1982-04-06Manufacturing (CMC) · Supplement 36 · standardAP
1982-04-06Labeling · Supplement 37 · standardAP
1982-03-08Manufacturing (CMC) · Supplement 38 · standardAP
1982-02-16Manufacturing (CMC) · Supplement 35 · standardAP
1981-12-16Manufacturing (CMC) · Supplement 34 · standardAP
1981-06-29Manufacturing (CMC) · Supplement 30 · standardAP
1981-06-17Manufacturing (CMC) · Supplement 28 · standardAP
1981-06-17Labeling · Supplement 29 · standardAP
1980-07-31Manufacturing (CMC) · Supplement 25 · standardAP
1980-06-03Manufacturing (CMC) · Supplement 24 · standardAP
1979-11-28Manufacturing (CMC) · Supplement 19 · standardAP
1979-11-28Labeling · Supplement 20 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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