Application 011210
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TESSALON | BENZONATATE | CAPSULE;ORAL | 100MG | Yes | No |
| 003 | TESSALON | BENZONATATE | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011210-001 | TESSALON | BENZONATATE | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | |
| N011210-003 | TESSALON | BENZONATATE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N011210-001 | AA |
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 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N011210-003 | TESSALON | 200MG | CAPSULE / ORAL | RLD | 1999-06-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N011210-003 | TESSALON | 200MG | CAPSULE / ORAL | RLD | 1999-06-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 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 | N011210-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N011210-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N011210-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011210-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N011210-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011210-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011210-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011210-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011210-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011210-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011210-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N011210-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011210-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011210-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011210-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N011210-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011210-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N011210-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N011210-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N011210-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N011210-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N011210-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N011210-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N011210-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N011210-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N011210-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N011210-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N011210-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N011210-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N011210-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N011210-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N011210-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N011210-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N011210-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N011210-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N011210-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N011210-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N011210-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N011210-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N011210-001 | AA | 1 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| BENZONATATE | BENZONATATE | DIRECT RX | bec39717-eb88-6ca1-e053-2a95a90a9d9d | 2025-01-17 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Zydus Lifesciences Limited | abb4360a-4c52-45b6-9b80-df3c1bfc4c59 | 2024-11-25 | BENZONATATE | |
| Benzonatate | BENZONATATE | Amneal Pharmaceuticals LLC | 199a42ae-4d19-4e68-934d-dabd27084988 | 2024-10-23 | Boxed warning, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | A-S Medication Solutions | 3268cde5-65ae-43d2-95c6-b8bb4c32a6fd | 2024-10-21 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | American Health Packaging | 9a71725a-64b6-4800-a79c-aa4b2d74d44f | 2024-09-30 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | NuCare Pharmaceuticals,Inc. | cfd54d90-c15d-0d02-e053-2995a90a8b28 | 2024-09-30 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | f32014c7-bc0c-4edb-b591-7baa6664d74b | 2024-09-29 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 5008eb9e-b209-4393-8d13-bb92976e8dde | 2024-08-20 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | NCS HealthCare of KY, LLC dba Vangard Labs | 6f5c19ad-d811-4196-a9c3-4f6b89626b83 | 2024-08-12 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 93f4935b-ba15-4a99-bfa9-96ca99a1ddc1 | 2024-08-07 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | NuCare Pharmaceuticals,Inc. | 941afb1f-348b-4340-e053-2995a90ac370 | 2024-07-17 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | NuCare Pharmaceuticals,Inc. | 9cab4544-e0ab-3fdd-e053-2995a90ad049 | 2024-06-20 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | NuCare Pharmaceuticals,Inc. | a2167f23-95bf-baa2-e053-2a95a90a7bbd | 2024-06-20 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | NuCare Pharmaceuticals,Inc. | 96b260c3-e177-73c3-e053-2a95a90a775e | 2024-06-19 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Rising Pharma Holdings, Inc. | 0ca22f92-9750-4eb4-8cdb-ebd3b12691cc | 2024-06-07 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f | 2024-05-23 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 77b51a56-43e8-4be0-b993-28b1cecdbf14 | 2024-03-15 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | A-S Medication Solutions | cf41278a-3fb6-4bcb-b86e-016a41314625 | 2024-01-29 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 9083ff4d-dd50-4931-b14f-cfa08fccba8b | 2024-01-12 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 2471d5d9-ea9e-482a-811d-ad173b253be7 | 2024-01-10 | Warnings, Adverse reactions | BENZONATATE |
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 |
|---|---|---|---|---|---|
| 0069-0122 | Tessalon | benzonatate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0122 | Tessalon | benzonatate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0122 | Tessalon | benzonatate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0122 | Tessalon | benzonatate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 59762-1122 | Benzonatate | benzonatate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1122 | Benzonatate | benzonatate | Greenstone LLC | NDA | Current |
| 59762-1122 | Benzonatate | benzonatate | Greenstone LLC | NDA | Current |