FDA : Aprobaciones de medicamentos nuevos y genéricos.

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Aprobaciones de medicamentos nuevos y genéricos

July 10, 2017

Nombre y

de drogas número de solicitud

Ingrediente activo

Forma de dosificación / formato

Submission

Compañía

Submission Classification

Submission Status

Avalide

NDA #020758

Hydrochlorothiazide; Irbesartan

Tablet; Oral

SUPPL-72

Sanofi Aventis Us

Labeling

Approved

Plavix

NDA #020839

Clopidogrel Bisulfate

Tablet; Oral

SUPPL-67

Sanofi Aventis Us

Labeling

Approved

Plavix

NDA #020839

Clopidogrel Bisulfate

Tablet; Oral

SUPPL-67

Sanofi Aventis Us

Labeling

Approved

Xyzal

NDA #022064

Levocetirizine Dihydrochloride

Tablet; Oral

SUPPL-33

Ucb Inc

Labeling

Approved

Xyzal

NDA #022157

Levocetirizine Dihydrochloride

Solution; Oral

SUPPL-16

Ucb Inc

Labeling

Approved

July 7, 2017

Busulfan

ANDA #205106

Busulfan

Injectable; Injection

ORIG-1

Sandoz Inc

 

Approved

Dabigatran Etexilate

ANDA #208046

Dabigatran Etexilate

Capsule; Oral

ORIG-1

Alembic Pharms Ltd

 

Tentative Approval

Doxazosin Mesylate

ANDA #208719

Doxazosin Mesylate

Tablet; Oral

ORIG-1

Zydus Pharms Usa Inc

 

Approved

Endari

NDA #208587

L-Glutamine

Powder; Oral

ORIG-1

Emmaus Medcl

Type 5 – New Formulation or New Manufacturer

Approved

Flucytosine

ANDA #204652

Flucytosine

Capsule; Oral

ORIG-1

Novel Labs Inc

 

Approved

Levoleucovorin

ANDA #207548

Levoleucovorin

Injectable; Injection

ORIG-1

Amneal Pharms Co

 

Tentative Approval

Linezolid

ANDA #207001

Linezolid

Solution; Iv (Infusion)

ORIG-1

Hq Spclt Pharma

 

Approved

Liquid E-Z-Paque

NDA #208143

Barium Sulfate

Suspension; Oral

SUPPL-4

Bracco

Efficacy

Approved

Lurasidone Hydrochloride

ANDA #208052

Lurasidone Hydrochloride

Tablet; Oral

ORIG-1

Zydus Pharms Usa

 

Tentative Approval

Octreotide Acetate (Preservative Free)

ANDA #079198

Octreotide Acetate

Injectable; Injection

SUPPL-5

Mylan Institutional

Labeling

Approved

Octreotide Acetate (Preservative Free)

ANDA #079198

Octreotide Acetate

Injectable; Injection

SUPPL-6

Mylan Institutional

Labeling

Approved

Octreotide Acetate (Preservative Free)

ANDA #079198

Octreotide Acetate

Injectable; Injection

SUPPL-5

Mylan Institutional

Labeling

Approved

Octreotide Acetate (Preservative Free)

ANDA #079198

Octreotide Acetate

Injectable; Injection

SUPPL-6

Mylan Institutional

Labeling

Approved

Pravastatin Sodium

ANDA #076341

Pravastatin Sodium

Tablet; Oral

SUPPL-19

Apotex Inc

Labeling

Approved

Pravastatin Sodium

ANDA #076341

Pravastatin Sodium

Tablet; Oral

SUPPL-19

Apotex Inc

Labeling

Approved

Readi-Cat 2

NDA #208143

Barium Sulfate

Suspension; Oral

SUPPL-4

Bracco

Efficacy

Approved

Readi-Cat 2 Smoothies

NDA #208143

Barium Sulfate

Suspension; Oral

SUPPL-4

Bracco

Efficacy

Approved

Reclast

NDA #021817

Zoledronic Acid

Injectable; Iv (Infusion)

SUPPL-27

Novartis

Labeling

Approved

Tetrabenazine

ANDA #206686

Tetrabenazine

Tablet; Oral

ORIG-1

Actavis Labs Fl Inc

 

Approved

Travoprost

ANDA #205050

Travoprost

Solution/Drops; Ophthalmic

ORIG-1

Mylan Pharms Inc

 

Approved