Application 210267
- Type
- ANDA
- Sponsor
- NOVAST LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | No | No |
| 002 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | No | No |
| 003 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210267-001 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | |
| A210267-002 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | |
| A210267-003 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210267-001 | AB |
| A210267-002 | AB |
| A210267-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210267-002 | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210267-003 | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210267-001 | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2019-03-12 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210267-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210267-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210267-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210267-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210267-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210267-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210267-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210267-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210267-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210267-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210267-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210267-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210267-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210267-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210267-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210267-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210267-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210267-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210267-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210267-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210267-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210267-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210267-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210267-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210267-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210267-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210267-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210267-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210267-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210267-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210267-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210267-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210267-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210267-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210267-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210267-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210267-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210267-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210267-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210267-001 | AB | 1 | 8072bd15b7f6… |
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 HCL | TIZANIDINE HCL | Advanced Rx of Tennessee, LLC | b353cdb8-75fa-7e3c-e053-2a95a90ada58 | 2025-12-05 | Warnings, Adverse reactions | 210267 ANDA210267 80425-0090 |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ae9b6808-632f-4204-8581-bf146dcab69f | 2025-09-30 | Warnings, Adverse reactions | 210267 ANDA210267 |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 4009c6cb-c183-2165-e063-6294a90aed78 | 2025-09-30 | Warnings, Adverse reactions | 210267 ANDA210267 |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 6439a7ef-1b22-4fa1-9be3-eedd3cd24191 | 2025-09-30 | Warnings, Adverse reactions | 210267 ANDA210267 |
| Tizanidine | TIZANIDINE | Direct_Rx | 0bdc188d-b895-acbc-e063-6294a90acd68 | 2025-08-19 | Warnings, Adverse reactions | 210267 ANDA210267 |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | Ingenus Pharmaceuticals, LLC | 99cc8f5f-b947-4ddc-99b6-1e4cef09b717 | 2025-01-10 | Warnings, Adverse reactions | 210267 ANDA210267 50742-224 50742-226 50742-225 |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 26f8f233-5dc2-0013-e063-6394a90ab0f5 | 2024-10-29 | Warnings, Adverse reactions | 210267 ANDA210267 |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | Bryant Ranch Prepack | ff7a82ea-c03c-44f6-9b15-468cb8d15a9c | 2024-04-05 | Warnings, Adverse reactions | 210267 ANDA210267 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50742-224 | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-224 | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-224 | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-225 | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-225 | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-225 | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-226 | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-226 | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-226 | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 80425-0090 | Zanaflex | Tizanidine HCl 4mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0090 | Tizanidine HCL | Tizanidine HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0090 | Tizanidine HCL | Tizanidine HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |