Home Applications 212865 Application 212865
Type ANDA
Sponsor CELLTRION Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREGABALIN PREGABALIN CAPSULE;ORAL 50MG No No 002 PREGABALIN PREGABALIN CAPSULE;ORAL 75MG No No 003 PREGABALIN PREGABALIN CAPSULE;ORAL 100MG No No 004 PREGABALIN PREGABALIN CAPSULE;ORAL 150MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212865-001 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 A212865-002 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 A212865-003 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 A212865-004 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 4 · 148 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 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 148 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 22 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71335-2000 Pregabalin pregabalin Bryant Ranch Prepack ANDA Current 71335-2012 Pregabalin pregabalin Bryant Ranch Prepack ANDA Current 71335-2015 Pregabalin pregabalin Bryant Ranch Prepack ANDA Current 71335-2030 Pregabalin pregabalin Bryant Ranch Prepack ANDA Current 72606-005 Pregabalin pregabalin CELLTRION USA, INC. ANDA Current 72606-005 Pregabalin pregabalin CELLTRION USA, INC. ANDA Current 72606-006 Pregabalin pregabalin CELLTRION USA, INC. ANDA Current 72606-006 Pregabalin pregabalin CELLTRION USA, INC. ANDA Current 72606-007 Pregabalin pregabalin CELLTRION USA, INC. ANDA Current 72606-007 Pregabalin pregabalin CELLTRION USA, INC. ANDA Current 72606-008 Pregabalin pregabalin CELLTRION USA, INC. ANDA Current 72606-008 Pregabalin pregabalin CELLTRION USA, INC. ANDA Current 76420-221 Pregabalin pregabalin Asclemed USA, Inc. ANDA Current 76420-221 Pregabalin pregabalin Asclemed USA, Inc. ANDA Current 76420-247 Pregabalin pregabalin Asclemed USA, Inc. ANDA Current 76420-247 Pregabalin pregabalin Asclemed USA, Inc. ANDA Current 76420-248 Pregabalin pregabalin Asclemed USA, Inc. ANDA Current 76420-249 Pregabalin pregabalin Asclemed USA, Inc. ANDA Current 76420-249 Pregabalin pregabalin Asclemed USA, Inc. ANDA Current 80425-0166 Lyrica Pregabalin 100mg Advanced Rx Pharmacy of Tennessee, LLC ANDA Current 80425-0166 Pregabalin Pregabalin Advanced Rx Pharmacy of Tennessee, LLC ANDA Current 80425-0166 Pregabalin Pregabalin Advanced Rx Pharmacy of Tennessee, LLC ANDA Current