Home Applications 076280 Application 076280
Type ANDA
Sponsor CASI PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE No No 002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076280-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 A076280-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27
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 · 84 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 2026-08-18 06:07:40 2026-07 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 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 2 of 2 · 34 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join tizanidine hydrochloride TIZANIDINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. e94aa8b1-74ed-46b7-94c5-53d5d5630be6 2025-05-16 Warnings, Adverse reactions Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE Zanaflex TIZANIDINE HYDROCHLORIDE Covis Pharma US, Inc 043d9e51-bfa2-4add-9058-5ece332f7e99 2025-05-05 Warnings, Adverse reactions Name fallback generic name: TIZANIDINE HYDROCHLORIDE Tizanidine hydrochloride TIZANIDINE HYDROCHLORIDE Modavar Pharmaceuticals LLC f8288ccd-6c66-415e-a06b-758971afe9a0 2025-01-29 Warnings, Adverse reactions Name fallback brand name: Tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TIZANIDINE HYDROCHLORIDE Bryant Ranch Prepack 58c10b87-004e-4d2d-b5c1-b353c2cd071f 2025-01-24 Warnings, Adverse reactions Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE Tizanidine Hydrochloride TIZANIDINE HYDROCHLORIDE Aurobindo Pharma Limited 19cf46b5-d8dc-44cb-83d6-bacea0870dbe 2025-01-17 Warnings, Adverse reactions Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE Ingenus Pharmaceuticals, LLC 99cc8f5f-b947-4ddc-99b6-1e4cef09b717 2025-01-10 Warnings, Adverse reactions Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE Tizanidine hydrochloride TIZANIDINE HYDROCHLORIDE Cadila Pharmaceuticals Limited f2f4e117-0318-4bbd-aaa7-fab803714f21 2024-12-23 Warnings, Adverse reactions Name fallback brand name: Tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE Tizanidine Hydrochloride TIZANIDINE HYDROCHLORIDE Alembic Pharmaceuticals Inc. ee3e9813-a738-46d1-9c05-c931aee1495c 2024-12-17 Warnings, Adverse reactions Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE Tizanidine Hydrochloride TIZANIDINE HYDROCHLORIDE Quality Care Products LLC 87f8a776-e8ae-4aed-a221-98ca72a2bedf 2024-12-16 Warnings, Adverse reactions Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE Advanced Rx of Tennessee, LLC 26f8f233-5dc2-0013-e063-6394a90ab0f5 2024-10-29 Warnings, Adverse reactions Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE Bryant Ranch Prepack ff7a82ea-c03c-44f6-9b15-468cb8d15a9c 2024-04-05 Warnings, Adverse reactions Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TIZANIDINE HYDROCHLORIDE Actavis Pharma, Inc. cb8b01b3-bcec-4762-9d67-0db018ef6b22 2023-03-10 Warnings, Adverse reactions Name fallback brand name: tizanidine hydrochloride generic name: TIZANIDINE HYDROCHLORIDE Tizanidine Hydrochloride TIZANIDINE HYDROCHLORIDE Alembic Pharmaceuticals Limited 29750221-497e-4747-a9b8-12a0c2236eae 2023-01-30 Warnings, Adverse reactions Name fallback brand name: Tizanidine Hydrochloride generic name: TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE Nivagen Pharmaceuticals, Inc. c4a5b305-4265-4f90-a9ff-c16c0b936a06 2021-01-14 Warnings, Adverse reactions Name fallback brand name: TIZANIDINE HYDROCHLORIDE generic name: TIZANIDINE HYDROCHLORIDE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0185-0034 tizanidine hydrochloride tizanidine hydrochloride Eon Labs, Inc. ANDA Current 0185-4400 tizanidine hydrochloride tizanidine hydrochloride Eon Labs, Inc. ANDA Current 43063-237 Comfort Pac with Tizanidine Tizanidine PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-784 tizanidine hydrochloride tizanidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-784 tizanidine hydrochloride tizanidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-784 tizanidine hydrochloride tizanidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-784 tizanidine hydrochloride tizanidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-784 tizanidine hydrochloride tizanidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-784 tizanidine hydrochloride tizanidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 63629-6537 tizanidine hydrochloride tizanidine hydrochloride Bryant Ranch Prepack ANDA Current 63629-6537 tizanidine hydrochloride tizanidine hydrochloride Bryant Ranch Prepack ANDA Current 68788-6431 tizanidine hydrochloride tizanidine hydrochloride Preferred Pharmaceuticals ANDA Current 71610-114 tizanidine hydrochloride tizanidine hydrochloride Aphena Pharma Solutions - Tennessee, LLC ANDA Current