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GRANIX

tbo-filgrastim · Injection, Solution

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
GRANIX
Generic name
tbo-filgrastim
Dosage form
Injection, Solution
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
Cephalon, LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
10
Data completeness
53% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Filgrastim 300 ug/.5mL 2595944 View
Filgrastim 300 ug/mL 2595944 View
Filgrastim 480 ug/.8mL 2595944 View
Filgrastim 480 ug/1.6mL 2595944 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Subcutaneous
Presentations
14

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Granulocyte Colony-Stimulating Factor [CS] CS All 10 members
Increased Myeloid Cell Production [PE] PE All 10 members
Leukocyte Growth Factor [EPC] EPC All 11 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
125294
Application type
BLA · Biologics License Application
Approval date
August 29, 2012
Sponsor
SICOR BIOTECH
Products on application
2
Submissions recorded
9
Products approved under application 125294.
Product Trade name Form Strength Ingredient Status TE Flags
125294-001 GRANIX INJECTABLE TBO-FILGRASTIM Prescription —
125294-002 GRANIX INJECTABLE TBO-FILGRASTIM Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 125294.
Type No. Action Status Date Review
Supplement 58 Labeling Approved November 21, 2023 Standard
Supplement 48 Labeling Approved October 9, 2019 Standard
Supplement 46 Labeling Approved March 28, 2019 Standard
Supplement 45 Efficacy Approved July 31, 2018 Priority
Supplement 42 Labeling Approved June 21, 2017 Standard
Supplement 40 Labeling Approved February 2, 2017 Standard
Supplement 35 Labeling Approved December 19, 2014 Standard
Supplement 7 Labeling Approved July 19, 2013 Standard
Original application 1 Type 1 - New Molecular Entity Approved August 29, 2012 Standard

Review documents

  • 0 · Supplement · November 24, 2023
  • 0 · Supplement · November 22, 2023
  • 0 · Supplement · October 10, 2019
  • 0 · Supplement · April 2, 2019
  • 0 · Supplement · March 29, 2019
  • 0 · Supplement · August 3, 2018
  • 0 · Supplement · August 2, 2018
  • 0 · Supplement · June 22, 2017
  • 0 · Supplement · June 22, 2017
  • 0 · Supplement · February 3, 2017
  • 0 · Supplement · February 3, 2017
  • 0 · Supplement · December 22, 2014
  • 0 · Supplement · July 23, 2013
  • 0 · Supplement · July 22, 2013
  • 0 · Original application · September 26, 2012
  • 0 · Original application · September 26, 2012
  • 0 · Original application · September 4, 2012
  • 0 · Original application · August 31, 2012
  • 0 · Supplement · January 1, 1900
  • 0 · Supplement · January 1, 1900
  • 0 · Supplement · January 1, 1900
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900

Adverse event reports

Source: openFDA FAERS
41,966
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: FILGRASTIM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II February 12, 2025 Teva Pharmaceuticals USA, Inc Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit Ongoing

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
63459-910-11 63459-910 Cephalon, LLC 1 BLISTER PACK in 1 CARTON (63459-910-11) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01) November 11, 2013
63459-910-15 63459-910 Cephalon, LLC 10 BLISTER PACK in 1 CARTON (63459-910-15) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01) November 11, 2013
63459-910-17 63459-910 Cephalon, LLC 1 SYRINGE, GLASS in 1 CARTON (63459-910-17) / .5 mL in 1 SYRINGE, GLASS (63459-910-18) March 2, 2015
63459-910-36 63459-910 Cephalon, LLC 5 SYRINGE, GLASS in 1 CARTON (63459-910-36) / .5 mL in 1 SYRINGE, GLASS (63459-910-18) March 2, 2015
63459-912-11 63459-912 Cephalon, LLC 1 BLISTER PACK in 1 CARTON (63459-912-11) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-912-12) / .8 mL in 1 SYRINGE, GLASS (63459-912-01) November 11, 2013
63459-912-15 63459-912 Cephalon, LLC 10 BLISTER PACK in 1 CARTON (63459-912-15) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-912-12) / .8 mL in 1 SYRINGE, GLASS (63459-912-01) November 11, 2013
63459-912-17 63459-912 Cephalon, LLC 1 SYRINGE, GLASS in 1 CARTON (63459-912-17) / .8 mL in 1 SYRINGE, GLASS (63459-912-18) March 2, 2015
63459-912-36 63459-912 Cephalon, LLC 5 SYRINGE, GLASS in 1 CARTON (63459-912-36) / .8 mL in 1 SYRINGE, GLASS (63459-912-18) March 2, 2015
63459-918-59 63459-918 Cephalon, LLC 10 VIAL in 1 CARTON (63459-918-59) / 1 mL in 1 VIAL (63459-918-53) November 7, 2018
63459-920-59 63459-920 Cephalon, LLC 10 VIAL in 1 CARTON (63459-920-59) / 1.6 mL in 1 VIAL (63459-920-53) November 7, 2018
63459-910 63459-910 Cephalon, LLC — November 11, 2013
63459-912 63459-912 Cephalon, LLC — November 11, 2013
63459-918 63459-918 Cephalon, LLC — November 7, 2018
63459-920 63459-920 Cephalon, LLC — November 7, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts
Enforcement FDA Recall records
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 10 sections on this page.