Application 012015
- Type
- NDA
- Sponsor
- OAK PHARMS AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COGENTIN | BENZTROPINE MESYLATE | INJECTABLE;INJECTION | 1MG/ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012015-001 | COGENTIN | BENZTROPINE MESYLATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |
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UTC | 2026-02 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N012015-001 | COGENTIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N012015-001 | COGENTIN | 1MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-04 05:41 UTC | 2022-04 | N012015-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N012015-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N012015-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N012015-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N012015-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N012015-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N012015-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N012015-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N012015-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N012015-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N012015-001 | AP | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | 241479dd-91bf-455a-80a1-1bb2d1c8156d | 2026-07-28 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | 01688e6f-7b22-41bf-9a85-1c88d90f99b6 | 2026-06-29 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | REMEDYREPACK INC. | 09e3e099-0b29-4ab5-bf35-5e41355dd454 | 2026-06-23 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Unit Dose Solutions, Inc. | 53c02a89-012c-e724-e063-6294a90acc75 | 2026-06-08 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Coupler LLC | 52bd605a-6a28-c2ec-e063-6294a90a8371 | 2026-05-26 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Coupler LLC | 513b1f4c-d253-6ad7-e063-6394a90a1dab | 2026-05-07 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Coupler LLC | 512ada3e-4b85-d989-e063-6394a90a9d54 | 2026-05-06 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Coupler LLC | 50c61b1d-49d6-37f2-e063-6294a90a0590 | 2026-05-01 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Coupler LLC | 5035534e-e15c-8f06-e063-6294a90a5003 | 2026-04-24 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | NCS HealthCare of KY, LLC dba Vangard Labs | bac9dfb7-aa09-4841-9e8f-cc41bb438fe2 | 2026-04-15 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | 7430b584-2812-4af5-994a-33dd1afed476 | 2026-03-24 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Navinta LLC | f92fbafa-314d-4449-831f-26108339e6b2 | 2026-03-17 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | DIRECT RX | 9b93035b-34d6-4084-ba73-5dea72f9d124 | 2026-03-17 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Bryant Ranch Prepack | ae749a71-d253-474d-a26c-bec780c5b09c | 2026-02-16 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | NCS HealthCare of KY, LLC dba Vangard Labs | df0647b8-2aa7-4aa4-9ba3-82c28698e7c5 | 2026-01-23 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | ScieGen Pharmaceuticals Inc | 1ead16a7-88ed-407d-b25a-0d9a1d9da5ef | 2026-01-09 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Bryant Ranch Prepack | 9270d14c-b885-4679-8871-6f2547450398 | 2026-01-07 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Bryant Ranch Prepack | 284e78af-7544-4c4a-8081-74e45501dc76 | 2026-01-07 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Chartwell RX, LLC. | c002005d-a478-48d4-b345-cb87edcb061f | 2025-12-09 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
| Benztropine Mesylate | BENZTROPINE MESYLATE | American Health Packaging | b7f915a9-cd53-4a74-8ee5-35ee5c5c991e | 2025-11-18 | Warnings, Adverse reactions | BENZTROPINE MESYLATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17478-012 | Benztropine Mesylate | Benztropine Mesylate | Akorn, Inc. | NDA AUTHORIZED GENERIC | Current |
| 17478-012 | Benztropine Mesylate | Benztropine Mesylate | Akorn, Inc. | NDA AUTHORIZED GENERIC | Current |
| 17478-012 | Benztropine Mesylate | Benztropine Mesylate | Akorn, Inc. | NDA AUTHORIZED GENERIC | Current |
| 17478-012 | Benztropine Mesylate | Benztropine Mesylate | Akorn | NDA AUTHORIZED GENERIC | Current |
| 64725-0012 | Benztropine Mesylate | Benztropine Mesylate | TYA Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 76478-611 | Cogentin | benztropine mesylate | Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) | NDA | Current |
| 76478-611 | Cogentin | benztropine mesylate | Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) | NDA | Current |
| 76478-611 | Cogentin | benztropine mesylate | Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) | NDA | Current |