Application 040795
- Type
- ANDA
- Sponsor
- NESHER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENZONATATE | BENZONATATE | CAPSULE;ORAL | 100MG | No | No |
| 002 | BENZONATATE | BENZONATATE | CAPSULE;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040795-001 | BENZONATATE | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | ||
| A040795-002 | BENZONATATE | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A040795-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-10-31 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A040795-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-10-31 | bb7c543d1eb4… |
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 | Redpharm Drug | 4972e1e4-7eac-a770-e063-6294a90abe28 | 2026-01-28 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | AvKARE | 0b50405c-d399-edcd-e063-6294a90a89c2 | 2026-01-14 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | Northwind Health Company, LLC | da6bcd14-2294-e7df-e053-2995a90a4526 | 2026-01-01 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | Northwind Health Company, LLC | da6cead3-2859-df03-e053-2a95a90a010b | 2026-01-01 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| BENZONATATE | BENZONATATE | Northwind Health Company, LLC | da807eb3-349e-61b9-e053-2995a90a0e21 | 2026-01-01 | Warnings, Adverse reactions | BENZONATATE BENZONATATE |
| Benzonatate | BENZONATATE | Redpharm Drug | 46e97547-23d9-114a-e063-6394a90a920b | 2025-12-27 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| BENZONATATE | BENZONATATE | QPharma, Inc. | 55c4ae18-3e37-4caf-9fdb-9d307970b5f9 | 2025-12-21 | Warnings, Adverse reactions | BENZONATATE BENZONATATE |
| Benzonatate | BENZONATATE | Redpharm Drug | 32524a8a-4cee-26c0-e063-6294a90aa898 | 2025-12-18 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| BENZONATATE | BENZONATATE | Coupler LLC | 463d5cff-3cd6-58fc-e063-6394a90a996b | 2025-12-18 | Warnings, Adverse reactions | BENZONATATE BENZONATATE |
| Benzonatate | BENZONATATE | QPharma Inc | fbd07fb0-c49c-a838-e053-6394a90a5f0e | 2025-12-03 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | Redpharm Drug | 44f2826e-20ff-b53c-e063-6394a90a9630 | 2025-12-02 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| BENZONATATE | BENZONATATE | Ascend Laboratories, LLC | 54374c04-63b9-49fa-b6a2-4a711e322d8e | 2025-12-02 | Warnings, Adverse reactions | BENZONATATE BENZONATATE |
| Benzonatate | BENZONATATE | A-S Medication Solutions | 1b5364d2-bbd5-4c05-a7b5-a5cdbf1d37e9 | 2025-12-01 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | a8d13a2b-b7cf-4c33-ad2f-fda5c7e598b9 | 2025-10-28 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | REMEDYREPACK INC. | 284a8cbb-632b-41ba-97b8-07fe70c14a83 | 2025-10-16 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 751d9d60-cd6b-4aa1-b68f-61b86c4059ad | 2025-08-26 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | a52856fc-049d-48cf-8cc4-de059850e31a | 2025-06-26 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 995ebc53-4e13-4c1d-b301-71ac83c6def8 | 2025-06-04 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | Asclemed USA, Inc. | 25ed5206-b322-486f-9e54-14125f6e74c5 | 2025-04-18 | Warnings, Adverse reactions | Benzonatate BENZONATATE |
| Benzonatate | BENZONATATE | RedPharm Drug, Inc. | a2f6acff-70ff-79f1-e053-2a95a90a6005 | 2025-04-09 | Warnings, Adverse reactions | Benzonatate BENZONATATE |