Home Applications 022544 Application 022544
Type NDA
Sponsor ALMATICA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GRALISE GABAPENTIN TABLET;ORAL 300MG Yes Yes 002 GRALISE GABAPENTIN TABLET;ORAL 600MG Yes Yes 003 GRALISE GABAPENTIN TABLET;ORAL 450MG Yes No 004 GRALISE GABAPENTIN TABLET;ORAL 750MG Yes No 005 GRALISE GABAPENTIN TABLET;ORAL 900MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022544-001 GRALISE GABAPENTIN 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 N022544-002 GRALISE GABAPENTIN 600MG TABLET / ORAL AB2 RLD 2011-01-28 N022544-003 GRALISE GABAPENTIN 450MG TABLET / ORAL AB RLD 2023-04-18 N022544-004 GRALISE GABAPENTIN 750MG TABLET / ORAL AB RLD 2023-04-18 N022544-005 GRALISE GABAPENTIN 900MG TABLET / ORAL AB RLD, RS 2023-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 · 142 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 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022544-003 GRALISE 450MG TABLET / ORAL AB RLD 2023-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022544-004 GRALISE 750MG TABLET / ORAL AB RLD 2023-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022544-005 GRALISE 900MG TABLET / ORAL AB RLD, RS 2023-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022544-003 GRALISE 450MG TABLET / ORAL AB RLD 2023-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022544-004 GRALISE 750MG TABLET / ORAL AB RLD 2023-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022544-005 GRALISE 900MG TABLET / ORAL AB RLD, RS 2023-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 91 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 244 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-002 7438927 2024-02-26 U-1114 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-002 7438927 2024-02-26 U-1114 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-002 7438927 2024-02-26 U-1114 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022544-002 7438927 2024-02-26 U-1114 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022544-002 7438927 2024-02-26 U-1114 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022544-002 7438927 2024-02-26 U-1114 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022544-002 7438927 2024-02-26 U-1114 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022544-002 7438927 2024-02-26 U-1114 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022544-002 7438927 2024-02-26 U-1114 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-001 7731989 2022-10-25 Drug product 2011-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-001 8192756 2022-10-25 U-1114 Drug product 2012-06-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-001 8252332 2022-10-25 U-1114 Drug product 2012-09-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-001 8333992 2022-10-25 U-1114 Drug product 2013-01-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-002 7731989 2022-10-25 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-002 8192756 2022-10-25 U-1114 Drug product 2012-06-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-002 8252332 2022-10-25 U-1114 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-002 8333992 2022-10-25 U-1114 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-002 7438927 2024-02-26 U-1114 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022544-001 7731989 2022-10-25 Drug product 2011-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-001 8192756 2022-10-25 U-1114 Drug product 2012-06-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-001 8252332 2022-10-25 U-1114 Drug product 2012-09-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-001 8333992 2022-10-25 U-1114 Drug product 2013-01-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-002 7731989 2022-10-25 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-002 8192756 2022-10-25 U-1114 Drug product 2012-06-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-002 8252332 2022-10-25 U-1114 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-002 8333992 2022-10-25 U-1114 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-002 7438927 2024-02-26 U-1114 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022544-001 7731989 2022-10-25 Drug product 2011-03-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022544-001 8192756 2022-10-25 U-1114 Drug product 2012-06-08 4b0b4de00fa7…
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 · 23 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 13913-004 Gralise gabapentin Assertio Therapeutics, Inc. NDA Current 13913-004 Gralise gabapentin Depomed, Inc. NDA Current 13913-004 Gralise gabapentin Assertio Therapeutics, Inc. NDA Current 13913-004 Gralise gabapentin Assertio Therapeutics, Inc. NDA Current 13913-004 Gralise gabapentin Assertio Therapeutics, Inc. NDA Current 13913-005 Gralise gabapentin Assertio Therapeutics, Inc. NDA Current 13913-005 Gralise gabapentin Depomed, Inc. NDA Current 13913-005 Gralise gabapentin Assertio Therapeutics, Inc. NDA Current 13913-005 Gralise gabapentin Assertio Therapeutics, Inc. NDA Current 13913-005 Gralise gabapentin Assertio Therapeutics, Inc. NDA Current 13913-006 Gralise gabapentin Assertio Therapeutics, Inc. NDA Current 13913-006 Gralise gabapentin Depomed, Inc. NDA Current 13913-006 Gralise gabapentin Assertio Therapeutics, Inc. NDA Current 50436-1262 Gralise gabapentin Unit Dose Services NDA Current 52427-803 Gralise gabapentin Almatica Pharma LLC NDA Current 52427-803 Gralise gabapentin Almatica Pharma LLC NDA Current 52427-803 Gralise gabapentin Almatica Pharma LLC NDA Current 52427-806 Gralise gabapentin Almatica Pharma LLC NDA Current 52427-806 Gralise gabapentin Almatica Pharma LLC NDA Current 52427-806 Gralise gabapentin Almatica Pharma LLC NDA Current 52427-815 Gralise gabapentin Almatica Pharma LLC NDA Current 52427-815 Gralise gabapentin Almatica Pharma LLC NDA Current 52427-815 Gralise gabapentin Almatica Pharma LLC NDA Current