Home Applications 218529 Application 218529
Type ANDA
Sponsor FOURRTS LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREGABALIN PREGABALIN CAPSULE;ORAL 25MG No No 002 PREGABALIN PREGABALIN CAPSULE;ORAL 50MG No No 003 PREGABALIN PREGABALIN CAPSULE;ORAL 75MG No No 004 PREGABALIN PREGABALIN CAPSULE;ORAL 100MG No No 005 PREGABALIN PREGABALIN CAPSULE;ORAL 150MG No No 006 PREGABALIN PREGABALIN CAPSULE;ORAL 200MG No No 007 PREGABALIN PREGABALIN CAPSULE;ORAL 225MG No No 008 PREGABALIN PREGABALIN CAPSULE;ORAL 300MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218529-001 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL AB 2026-02-24 A218529-002 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2026-02-24 A218529-003 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2026-02-24 A218529-004 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2026-02-24 A218529-005 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2026-02-24 A218529-006 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL AB 2026-02-24 A218529-007 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL AB 2026-02-24 A218529-008 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL AB 2026-02-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 8 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-001 PREGABALIN 25MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-002 PREGABALIN 50MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-003 PREGABALIN 75MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-004 PREGABALIN 100MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-005 PREGABALIN 150MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-006 PREGABALIN 200MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-007 PREGABALIN 225MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-008 PREGABALIN 300MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-003 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-004 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-005 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-006 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-007 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-008 AB 1 a50c72e98297…
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 PREGABALIN PREGABALIN FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED 9bdea600-b561-4049-aa1c-3867b62fc1d3 2026-03-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 218529 application number: ANDA218529