Application 076286
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076286-001 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | |
| A076286-002 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076286-001 | AB |
| A076286-002 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076286-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2002-07-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076286-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2002-07-03 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076286-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076286-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076286-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076286-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076286-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076286-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076286-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076286-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076286-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076286-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076286-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076286-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076286-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076286-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076286-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076286-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076286-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076286-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076286-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076286-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076286-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076286-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076286-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076286-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076286-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076286-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076286-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076286-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076286-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076286-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076286-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076286-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076286-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076286-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076286-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076286-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076286-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076286-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076286-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076286-002 | AB | 1 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tizanidine | TIZANIDINE | Proficient Rx LP | c2353d09-3cb4-486e-8ae7-29339c1ba76b | 2025-02-01 | Warnings, Adverse reactions | 076286 ANDA076286 63187-009 |
| Tizanidine | TIZANIDINE | NorthStar Rx LLC | eed74219-9d4a-fecd-1bb9-ad6c01ad3e9d | 2025-01-27 | Warnings, Adverse reactions | 076286 ANDA076286 16714-172 16714-171 |
| Tizanidine | TIZANIDINE | NuCare Pharmaceuticals,Inc. | a7470959-8943-215b-e053-2a95a90a7878 | 2025-01-10 | Warnings, Adverse reactions | 076286 ANDA076286 68071-5268 |
| Tizanidine Hydrochloride | TIZANIDINE HYDROCHLORIDE | Quality Care Products LLC | 87f8a776-e8ae-4aed-a221-98ca72a2bedf | 2024-12-16 | Warnings, Adverse reactions | 076286 ANDA076286 49999-347 |
| Tizanidine | TIZANIDINE | Quality Care Products, LLC | b68a9f81-7138-48cf-b987-b8d284e8105a | 2024-12-11 | Warnings, Adverse reactions | 076286 ANDA076286 35356-662 |
| Tizanidine | TIZANIDINE | Dr. Reddy's Laboratories Limited | a42f3479-f2c2-8214-d547-c5cae9bfed1e | 2024-12-11 | Warnings, Adverse reactions | 076286 ANDA076286 55111-179 55111-180 |
| Tizanidine | TIZANIDINE | Asclemed USA, Inc. | 81385ce2-1d82-4987-8e18-83c823e10b99 | 2024-10-29 | Warnings, Adverse reactions | 076286 ANDA076286 |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 492c99bd-2cd0-43be-bd70-800b739b7e83 | 2024-01-08 | Warnings, Adverse reactions | 076286 ANDA076286 |
| Tizanidine | TIZANIDINE | A-S Medication Solutions | 67b2af93-92c9-4c33-8fa0-548bfcc9c538 | 2023-10-18 | Warnings, Adverse reactions | 076286 ANDA076286 |
| Tizanidine | TIZANIDINE | A-S Medication Solutions | 247ae1f4-6ec8-4e34-aae4-13495d8f64e5 | 2023-10-18 | Warnings, Adverse reactions | 076286 ANDA076286 |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | b254a0f4-efb1-4874-ae45-1dc5fe316964 | 2021-12-27 | Warnings, Adverse reactions | 076286 ANDA076286 63629-1673 |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 82084f4e-00d0-c298-c13a-88a6c0860b02 | 2021-12-08 | Warnings, Adverse reactions | 076286 ANDA076286 63629-3209 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-5574 | Tizanidine | Tizanidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6564 | Tizanidine | Tizanidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-890 | Tizanidine | Tizanidine | Blenheim Pharmacal, Inc. | ANDA | Current |
| 16714-171 | Tizanidine | Tizanidine | NorthStar Rx LLC | ANDA | Current |
| 16714-172 | Tizanidine | Tizanidine | NorthStar Rx LLC | ANDA | Current |
| 33261-103 | Tizanidine | Tizanidine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-104 | Tizanidine | Tizanidine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-662 | Tizanidine | Tizanidine | Quality Care Products, LLC | ANDA | Current |
| 35356-662 | Tizanidine | Tizanidine | Quality Care Products, LLC | ANDA | Current |
| 35356-662 | Tizanidine | Tizanidine | Quality Care Products, LLC | ANDA | Current |
| 43063-455 | Tizanidine | Tizanidine | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-455 | Tizanidine | Tizanidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-455 | Tizanidine | Tizanidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-455 | Tizanidine | Tizanidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-455 | Tizanidine | Tizanidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-455 | Tizanidine | Tizanidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-455 | Tizanidine | Tizanidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-455 | Tizanidine | Tizanidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-348 | Tizanidine | Tizanidine | Medsource Pharmaceuticals | ANDA | Current |
| 45865-386 | Tizanidine | Tizanidine | Medsource Pharmaceuticals | ANDA | Current |
| 49999-347 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-347 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-347 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-347 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-0811 | Tizanidine | Tizanidine | A-S Medication Solutions | ANDA | Current |
| 50090-0811 | Tizanidine | Tizanidine | A-S Medication Solutions | ANDA | Current |
| 50090-0811 | Tizanidine | Tizanidine | A-S Medication Solutions | ANDA | Current |
| 50090-0811 | Tizanidine | Tizanidine | A-S Medication Solutions | ANDA | Current |
| 50090-0811 | Tizanidine | Tizanidine | A-S Medication Solutions | ANDA | Current |
| 50090-0840 | Tizanidine | Tizanidine | A-S Medication Solutions | ANDA | Current |
| 50090-0840 | Tizanidine | Tizanidine | A-S Medication Solutions | ANDA | Current |
| 50090-0840 | Tizanidine | Tizanidine | A-S Medication Solutions | ANDA | Current |
| 50268-759 | Tizanidine | Tizanidine | AvPAK | ANDA | Current |
| 50268-759 | Tizanidine | Tizanidine | AvPAK | ANDA | Current |
| 50268-760 | Tizanidine | Tizanidine | AvPAK | ANDA | Current |
| 50268-760 | Tizanidine | Tizanidine | AvPAK | ANDA | Current |
| 50436-1180 | Tizanidine | Tizanidine | Unit Dose Services | ANDA | Current |
| 50436-6755 | Tizanidine | Tizanidine | Unit Dose Services | ANDA | Current |
| 50436-6756 | Tizanidine | Tizanidine | Unit Dose Services | ANDA | Current |
| 52959-689 | Tizanidine | Tizanidine | H.J. Harkins Company, Inc. | ANDA | Current |
| 52959-691 | Tizanidine | Tizanidine | H.J. Harkins Company, Inc. | ANDA | Current |
| 55111-179 | Tizanidine | Tizanidine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-179 | Tizanidine | Tizanidine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-180 | Tizanidine | Tizanidine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-180 | Tizanidine | Tizanidine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 60760-505 | Tizanidine | Tizanidine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-505 | Tizanidine | Tizanidine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-505 | Tizanidine | Tizanidine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-505 | Tizanidine | Tizanidine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-694 | Tizanidine | Tizanidine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-694 | Tizanidine | Tizanidine | St Mary's Medical Park Pharmacy | ANDA | Current |
| 63187-009 | Tizanidine | Tizanidine | Proficient Rx LP | ANDA | Current |
| 63187-009 | Tizanidine | Tizanidine | Proficient Rx LP | ANDA | Current |
| 63187-009 | Tizanidine | Tizanidine | Proficient Rx LP | ANDA | Current |
| 63629-1673 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-1673 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-3209 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-3209 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63874-087 | Tizanidine | Tizanidine | Altura Pharmaceuticals, Inc. | ANDA | Current |
| 66336-843 | Tizanidine | Tizanidine | Dispensing Solutions, Inc. | ANDA | Current |
| 67296-1417 | Tizanidine | Tizanidine | RedPharm Drug, Inc. | ANDA | Current |
| 68071-5268 | Tizanidine | Tizanidine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5268 | Tizanidine | Tizanidine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5268 | Tizanidine | Tizanidine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5268 | Tizanidine | Tizanidine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-645 | Tizanidine | Tizanidine | American Health Packaging | ANDA | Current |
| 68084-645 | Tizanidine | Tizanidine | American Health Packaging | ANDA | Current |
| 68084-645 | Tizanidine | Tizanidine | American Health Packaging | ANDA | Current |
| 68084-775 | Tizanidine | Tizanidine | American Health Packaging | ANDA | Current |
| 68084-775 | Tizanidine | Tizanidine | American Health Packaging | ANDA | Current |
| 68084-775 | Tizanidine | Tizanidine | American Health Packaging | ANDA | Current |
| 68788-7781 | Tizanidine | Tizanidine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7781 | Tizanidine | Tizanidine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7781 | Tizanidine | Tizanidine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7991 | Tizanidine | Tizanidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7991 | Tizanidine | Tizanidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9091 | Tizanidine | Tizanidine | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 68788-9092 | Tizanidine | Tizanidine | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 70518-0133 | Tizanidine | Tizanidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0133 | Tizanidine | Tizanidine | REMEDYREPACK INC. | ANDA | Current |