Home Applications 208113 Application 208113
Type ANDA
Sponsor REGCON HOLDINGS 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 150MG No No 004 PREGABALIN PREGABALIN CAPSULE;ORAL 75MG No No 005 PREGABALIN PREGABALIN CAPSULE;ORAL 100MG 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 A208113-001 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 A208113-002 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 A208113-003 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 A208113-004 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 A208113-005 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 A208113-006 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 A208113-007 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 A208113-008 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17
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.
Product history page 1 of 3 · 112 observed 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 A208113-001 PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-002 PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-003 PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-004 PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-005 PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-006 PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-007 PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-008 PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-001 PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-002 PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-003 PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-004 PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-005 PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-006 PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-007 PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-008 PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208113-001 PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-002 PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-003 PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-004 PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-005 PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-006 PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-007 PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-008 PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-001 PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-002 PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-003 PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-004 PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-005 PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-006 PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-007 PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-008 PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-001 PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-002 PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-003 PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-004 PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-005 PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-006 PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-007 PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-008 PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 112 observed states.
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.