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Details for Generic Name: somatropin recombinant

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Summary for Generic Name: somatropin recombinant

Drug Master File Entries: see list2
Suppliers: see list8

Pharmacology for Ingredient: somatropin recombinant

Clinical Trials for: somatropin recombinant

Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated at Least 3 Years or Until Near Final Height, When Applicable, in Comparison With a Historic Cohort of Non-treated Children
Status: Active, not recruiting Condition: Hypochondroplasia

Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
Status: Recruiting Condition: Traumatic Brain Injury

Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant
Status: Terminated Condition: Allogeneic Stem Cell Transplantation

rHGH and Intestinal Permeability in Intestinal Failure
Status: Active, not recruiting Condition: Short Bowel Syndrome

A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA)
Status: Terminated Condition: Infant, Small for Gestational Age

Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
Status: Completed Condition: HIV-Associated Lipodystrophy Syndrome; Insulin Resistance; HIV Infections; Metabolic Syndrome X; Body Weight Changes

Safety and Efficacy Trial of Serostim® in the Treatment of Subjects With Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)
Status: Completed Condition: Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS); Human Immunodeficiency Virus Infections

Effect of Cytokines on Growth of Children With Chronic Kidney Failure
Status: Suspended Condition: Chronic Renal Insufficiency

Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency
Status: Completed Condition: Childhood-onset Growth Hormone Deficiency; Pituitary Dwarfism

Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
Status: Active, not recruiting Condition: Obesity

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn
somatropin recombinant
INJECTABLE;INJECTION020280Oct 23, 1996RXYes<disabled><disabled>
somatropin recombinant
INJECTABLE;INJECTION021075Dec 22, 1999DISCNNo5,656,297<disabled><disabled>
Novo Nordisk Inc
somatropin recombinant
INJECTABLE;INJECTION021148Mar 1, 2010RXNo5,849,700<disabled><disabled>
Novo Nordisk Inc
somatropin recombinant
INJECTABLE;INJECTION021148Oct 1, 2004DISCNNoRE41956<disabled>Y<disabled>
Emd Serono
somatropin recombinant
INJECTABLE;INJECTION021597Dec 1, 2003RXYes5,898,030<disabled>Y<disabled>
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