Small For Gestational Age

• FDA approval · 2025-07-09
  FDA Approved: OMNITROPE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for OMNITROPE (somatropin) submitted by Sandoz Inc.

• FDA approval · 2025-01-31
  FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Norditropin (somatropin) from Novo Nordisk.

• FDA approval · 2020-03-09
  FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Norditropin (somatropin) by Novo Nordisk under BLA021148. The action pertains to changes approve…

• FDA approval · 2020-01-08
  FDA Approved: GENOTROPIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved Genotropin (somatropin) via a supplemental application submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2018-01-30
  FDA Approved: ZOMACTON — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for ZOMACTON (somatropin) by Ferring Pharmaceuticals. The action updates the product's indications o…

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• FDA approval · 2016-06-23
  FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)

  FDA approves a supplemental application for Norditropin (somatropin) from Novo Nordisk, indicating changes to labeling and/or indications.

• FDA approval · 2016-03-17
  FDA Approved: NUTROPIN AQ NUSPIN 10 — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Nutropin AQ Nuspin 10 (somatropin) by Genentech, Inc.

• FDA approval · 2016-02-26
  FDA Approved: NUTROPIN AQ NUSPIN 10 — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Nutropin AQ Nuspin 10 (somatropin) from Genentech, Inc., updating/expanding the product’s approv…

• FDA approval · 2015-06-12
  FDA Approved: ZOMACTON — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for ZOMACTON (somatropin) from Ferring Pharmaceuticals, likely to update labeling or expand indicati…

• FDA approval · 2015-05-26
  FDA Approved: NUTROPIN AQ NUSPIN 10 — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Nutropin AQ Nuspin 10 (somatropin) from Genentech, adding/confirming a formulation strength unde…

• FDA approval · 2015-01-23
  FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Norditropin (somatropin) from Novo Nordisk, resulting in an approved supplemental indication/lab…

• FDA approval · 2014-07-30
  FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Humatrope (somatropin) from Eli Lilly and Company.

• FDA approval · 2013-04-19
  FDA Approved: GENOTROPIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA supplemental approval for Genotropin (somatropin) from Pfizer, authorizing an approved supplemental application to modify or expand its …

• FDA approval · 2013-04-04
  FDA Approved: OMNITROPE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Omnitrope (somatropin) from Sandoz Inc, potentially expanding or updating the product’s labe…

• FDA approval · 2010-07-28
  FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMATROPE (somatropin) submitted by Eli Lilly and Company, authorizing changes to the existing p…

• FDA approval · 2010-04-12
  FDA Approved: ZOMACTON — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for ZOMACTON (somatropin) from Ferring Pharmaceuticals Inc. The action represents an additional regu…

• FDA approval · 2006-11-01
  FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for HUMATROPE (somatropin) submitted by Eli Lilly and Company.

• FDA approval · 2006-10-26
  FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for HUMATROPE (somatropin) submitted by Eli Lilly and Company.