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 44 .
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 · 157 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 2026-10-15 13:18:30 2026-09 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022544-003 GRALISE 450MG TABLET / ORAL AB RLD 2023-04-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022544-004 GRALISE 750MG TABLET / ORAL AB RLD 2023-04-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022544-005 GRALISE 900MG TABLET / ORAL AB RLD, RS 2023-04-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022544-003 GRALISE 450MG TABLET / ORAL AB RLD 2023-04-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022544-004 GRALISE 750MG TABLET / ORAL AB RLD 2023-04-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022544-005 GRALISE 900MG TABLET / ORAL AB RLD, RS 2023-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022544-003 GRALISE 450MG TABLET / ORAL AB RLD 2023-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022544-004 GRALISE 750MG TABLET / ORAL AB RLD 2023-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022544-005 GRALISE 900MG TABLET / ORAL AB RLD, RS 2023-04-18 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 106 observed states.
Observed Orange Book patent history# Patent history page 2 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 2022-04-04 05:41 UTC 2022-04 N022544-001 8252332 2022-10-25 U-1114 Drug product 2012-09-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022544-001 8333992 2022-10-25 U-1114 Drug product 2013-01-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022544-002 7731989 2022-10-25 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022544-002 8192756 2022-10-25 U-1114 Drug product 2012-06-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022544-002 8252332 2022-10-25 U-1114 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022544-002 8333992 2022-10-25 U-1114 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022544-002 7438927 2024-02-26 U-1114 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022544-001 6488962 2020-06-20 Drug product 2011-03-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-001 6723340 2021-10-25 Drug product 2011-03-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-001 7731989 2022-10-25 Drug product 2011-03-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-001 8192756 2022-10-25 U-1114 Drug product 2012-06-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-001 8252332 2022-10-25 U-1114 Drug product 2012-09-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-001 8333992 2022-10-25 U-1114 Drug product 2013-01-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-002 6488962 2020-06-20 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-002 6723340 2021-10-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-002 7731989 2022-10-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-002 8192756 2022-10-25 U-1114 Drug product 2012-06-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-002 8252332 2022-10-25 U-1114 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-002 8333992 2022-10-25 U-1114 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022544-002 7438927 2024-02-26 U-1114 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022544-001 7731989 2022-10-25 Drug product 2011-03-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022544-001 8192756 2022-10-25 U-1114 Drug product 2012-06-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022544-001 8252332 2022-10-25 U-1114 Drug product 2012-09-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022544-001 8333992 2022-10-25 U-1114 Drug product 2013-01-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022544-002 7731989 2022-10-25 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022544-002 8192756 2022-10-25 U-1114 Drug product 2012-06-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022544-002 8252332 2022-10-25 U-1114 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022544-002 8333992 2022-10-25 U-1114 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022544-002 7438927 2024-02-26 U-1114 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022544-001 6723340 2021-10-25 Drug product 2011-03-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022544-001 7731989 2022-10-25 Drug product 2011-03-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022544-001 8192756 2022-10-25 U-1114 Drug product 2012-06-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022544-001 8252332 2022-10-25 U-1114 Drug product 2012-09-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022544-001 8333992 2022-10-25 U-1114 Drug product 2013-01-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022544-002 6723340 2021-10-25 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022544-002 7731989 2022-10-25 Drug product 782e0a99824c…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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