Home Applications 214741 Application 214741
Type ANDA
Sponsor SCINOPHARM TAIWAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GLATIRAMER ACETATE GLATIRAMER ACETATE INJECTABLE;SUBCUTANEOUS 20MG/ML No No 002 GLATIRAMER ACETATE GLATIRAMER ACETATE INJECTABLE;SUBCUTANEOUS 40MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214741-001 GLATIRAMER ACETATE GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 A214741-002 GLATIRAMER ACETATE GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A214741-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214741-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214741-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214741-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214741-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214741-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Glatiramer Acetate GLATIRAMER ACETATE INJECTION UPSHER-SMITH LABORATORIES, LLC 707a64ef-964e-44a3-8a0f-fcc2eb5b1af2 2026-01-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214741 application number: ANDA214741