FDA.reportPublic FDA data

Application 213382

Type
ANDA
Sponsor
HYBIO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLATIRAMER ACETATEGLATIRAMER ACETATEINJECTABLE;SUBCUTANEOUS20MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213382-001GLATIRAMER ACETATEGLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2026-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A213382-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213382-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2026-02-1184e616aacf4f…
2026-08-18 06:07:402026-07A213382-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2026-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213382-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2026-02-11011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213382-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2026-02-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213382-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A213382-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213382-001AP1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213382-001AP1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glatiramer AcetateGLATIRAMER ACETATEAJENAT PHARMACEUTICALS LLC1ec10223-880d-402f-a759-9cd179bf09de2026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glatiramer Acetate
generic name: GLATIRAMER ACETATE
GLATIRAMER ACETATEGLATIRAMER ACETATEZydus Pharmaceuticals USA Inc.0aa4ff2a-ce8e-46cd-830f-a264cc582be22026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: GLATIRAMER ACETATE
generic name: GLATIRAMER ACETATE
GlatopaGLATIRAMER ACETATESandoz Inc5f01e40a-b6f6-40fb-b37c-3d06f1428e862026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GLATIRAMER ACETATE
CopaxoneGLATIRAMER ACETATETeva Neuroscience, Inc.aa88f583-4f5f-433b-80b4-1f4c9fb283572026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GLATIRAMER ACETATE
Glatiramer AcetateGLATIRAMER ACETATE INJECTIONUPSHER-SMITH LABORATORIES, LLC707a64ef-964e-44a3-8a0f-fcc2eb5b1af22026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glatiramer Acetate
GLATIRAMER ACETATEGLATIRAMER ACETATEItalfarmaco SpA1b3a60de-2191-4b15-be69-01329da877112025-10-31Name fallback
brand name: GLATIRAMER ACETATE
generic name: GLATIRAMER ACETATE
GlatopaGLATIRAMER ACETATEBryant Ranch Prepack0679689e-8930-4d6a-b922-5125082b27162025-03-27Warnings, Adverse reactionsName fallback
generic name: GLATIRAMER ACETATE
GlatopaGLATIRAMER ACETATEBryant Ranch Prepack028fdf0e-2340-407b-bcd8-5a99accdddbf2025-03-27Warnings, Adverse reactionsName fallback
generic name: GLATIRAMER ACETATE
Glatiramer AcetateGLATIRAMER ACETATESun Pharmaceutical Industries, Inc.f90cc5f5-56a1-48dc-a4fc-0ae89ef61deb2025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glatiramer Acetate
generic name: GLATIRAMER ACETATE
Glatiramer AcetateGLATIRAMER ACETATESun Pharmaceutical Industries, Inc.dfacc3e2-5c91-41de-a377-873276a5cf672025-02-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glatiramer Acetate
generic name: GLATIRAMER ACETATE
Glatiramer AcetateGLATIRAMER ACETATEMylan Pharmaceuticals Inc.f38b5606-d2d7-44ec-912f-46882aa2fa7b2025-02-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glatiramer Acetate
generic name: GLATIRAMER ACETATE
Glatiramer AcetateGLATIRAMERMylan Pharmaceuticals Inc.456a34c7-8511-4000-99a7-ad8f8de6d35e2025-02-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glatiramer Acetate

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.