Home Applications 218775 Application 218775
Type ANDA
Sponsor HEBEI CHANGSHAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) No No 002 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) No No 003 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) No No 004 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) No No 005 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) No No 006 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) No No 007 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218775-001 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM 30MG/0.3ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 A218775-002 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM 40MG/0.4ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 A218775-003 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM 60MG/0.6ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 A218775-004 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM 80MG/0.8ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 A218775-005 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM 100MG/ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 A218775-006 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM 120MG/0.8ML (150MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 A218775-007 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM 150MG/ML (150MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 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 2026-02-19 14:30 UTC 2026-02 A218775-001 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 30MG/0.3ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218775-002 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 40MG/0.4ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218775-003 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 60MG/0.6ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218775-004 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 80MG/0.8ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218775-005 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 100MG/ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218775-006 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 120MG/0.8ML (150MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218775-007 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 150MG/ML (150MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218775-001 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 30MG/0.3ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218775-002 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 40MG/0.4ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218775-003 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 60MG/0.6ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218775-004 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 80MG/0.8ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218775-005 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 100MG/ML (100MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218775-006 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 120MG/0.8ML (150MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218775-007 ENOXAPARIN SODIUM (PRESERVATIVE FREE) 150MG/ML (150MG/ML) INJECTABLE / SUBCUTANEOUS AP 2026-01-07 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 enoxaparin sodium ENOXAPARIN SODIUM Hebei Changshan Biochemical Pharmaceutical Co., Ltd. 7fa78f8d-92d9-434a-8e26-b886ab0ae77f 2026-01-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218775 application number: ANDA218775