Application 021615
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RAZADYNE ER | GALANTAMINE HYDROBROMIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 8MG BASE | Yes | Yes |
| 002 | RAZADYNE ER | GALANTAMINE HYDROBROMIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 16MG BASE | Yes | No |
| 003 | RAZADYNE ER | GALANTAMINE HYDROBROMIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 24MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021615-001 | RAZADYNE ER | GALANTAMINE HYDROBROMIDE | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | |
| N021615-002 | RAZADYNE ER | GALANTAMINE HYDROBROMIDE | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | |
| N021615-003 | RAZADYNE ER | GALANTAMINE HYDROBROMIDE | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 |
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2026-02 | N021615-001 | RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021615-002 | RAZADYNE ER | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021615-003 | RAZADYNE ER | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021615-001 | RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021615-002 | RAZADYNE ER | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021615-003 | RAZADYNE ER | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021615-001 | RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021615-002 | RAZADYNE ER | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021615-003 | RAZADYNE ER | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021615-001 | RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021615-002 | RAZADYNE ER | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021615-003 | RAZADYNE ER | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021615-001 | RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021615-002 | RAZADYNE ER | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021615-003 | RAZADYNE ER | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021615-001 | RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021615-002 | RAZADYNE ER | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021615-003 | RAZADYNE ER | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021615-001 | RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021615-002 | RAZADYNE ER | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021615-003 | RAZADYNE ER | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021615-001 | RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021615-002 | RAZADYNE ER | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021615-003 | RAZADYNE ER | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021615-001 | RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021615-002 | RAZADYNE ER | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021615-003 | RAZADYNE ER | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021615-001 | RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021615-002 | RAZADYNE ER | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021615-003 | RAZADYNE ER | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021615-001 | RAZADYNE ER | EQ 8MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021615-002 | RAZADYNE ER | EQ 16MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021615-003 | RAZADYNE ER | EQ 24MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021615-001 | RAZADYNE ER | EQ 8MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021615-002 | RAZADYNE ER | EQ 16MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021615-003 | RAZADYNE ER | EQ 24MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021615-001 | RAZADYNE ER | EQ 8MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021615-002 | RAZADYNE ER | EQ 16MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021615-003 | RAZADYNE ER | EQ 24MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021615-001 | RAZADYNE ER | EQ 8MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2005-04-01 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021615-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021615-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021615-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021615-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021615-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021615-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021615-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021615-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021615-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021615-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021615-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021615-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021615-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021615-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021615-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021615-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021615-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021615-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021615-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021615-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021615-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021615-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021615-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021615-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021615-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021615-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021615-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021615-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021615-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021615-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021615-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021615-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021615-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021615-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021615-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021615-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021615-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021615-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021615-003 | AB | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021615-001 | AB | 1 | a67488948f0b… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021615-001 | 7160559 | 2019-12-20 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021615-002 | 7160559 | 2019-12-20 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021615-003 | 7160559 | 2019-12-20 | Drug product | 74a2ff9319b5… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021615-001 | 7160559 | 2019-12-20 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021615-002 | 7160559 | 2019-12-20 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021615-003 | 7160559 | 2019-12-20 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021615-001 | 7160559 | 2019-12-20 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021615-002 | 7160559 | 2019-12-20 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021615-003 | 7160559 | 2019-12-20 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021615-001 | 7160559 | 2019-12-20 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021615-002 | 7160559 | 2019-12-20 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021615-003 | 7160559 | 2019-12-20 | Drug product | 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 |
|---|---|---|---|---|---|---|
| Galantamine Hydrobromide | GALANTAMINE HYDROBROMIDE | Bryant Ranch Prepack | 0f74a146-f6ee-4910-82a3-177153526dd0 | 2025-09-12 | Warnings, Adverse reactions | GALANTAMINE HYDROBROMIDE |
| Galantamine Hydrobromide | GALANTAMINE HYDROBROMIDE | Bryant Ranch Prepack | 3059d10f-fb3d-4cbd-b936-104608889b67 | 2024-08-12 | Warnings, Adverse reactions | GALANTAMINE HYDROBROMIDE |
| Galantamine Hydrobromide | GALANTAMINE HYDROBROMIDE | Bryant Ranch Prepack | db5b6c1e-449b-413f-b0cc-ca2133aa4986 | 2024-08-12 | Warnings, Adverse reactions | GALANTAMINE HYDROBROMIDE |
| Galantamine Hydrobromide | GALANTAMINE HYDROBROMIDE | Bryant Ranch Prepack | 3e7e2839-a834-4464-a82a-7554e10ad004 | 2024-08-12 | Warnings, Adverse reactions | GALANTAMINE HYDROBROMIDE |
| Galantamine Hydrobromide | GALANTAMINE HYDROBROMIDE | Bryant Ranch Prepack | 5cd99bc0-0f18-4800-a0f5-a94eebf0eead | 2024-04-08 | Warnings, Adverse reactions | GALANTAMINE HYDROBROMIDE |
| Galantamine Hydrobromide | GALANTAMINE HYDROBROMIDE | Bryant Ranch Prepack | c44108aa-bf20-4d45-b36f-d117320a675b | 2024-04-08 | Warnings, Adverse reactions | GALANTAMINE HYDROBROMIDE |
| Galantamine Hydrobromide | GALANTAMINE HYDROBROMIDE | Sun Pharmaceutical Industries, Inc. | d1697161-ebe8-42b0-83e7-c9de4412546c | 2023-10-26 | Warnings, Adverse reactions | GALANTAMINE HYDROBROMIDE |
| Galantamine Hydrobromide | GALANTAMINE HYDROBROMIDE | Hikma Pharmaceuticals USA Inc. | d5b0e225-e94d-4324-afb2-b6e51c949dd0 | 2023-10-25 | Warnings, Adverse reactions | GALANTAMINE HYDROBROMIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10147-0891 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0891 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0891 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0891 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0891 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0891 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0891 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0891 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0892 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0892 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0892 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0892 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0892 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0892 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0892 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0892 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0893 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0893 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0893 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0893 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0893 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0893 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0893 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 10147-0893 | galantamine hydrobromide | galantamine hydrobromide | Patriot Pharmaceuticals, LLC | NDA | Current |
| 50458-387 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-387 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-387 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-387 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-387 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-387 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-387 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-387 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-388 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-388 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-388 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-388 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-388 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-388 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-388 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-388 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-389 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-389 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-389 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-389 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-389 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-389 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-389 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-389 | RAZADYNE | galantamine hydrobromide | Janssen Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72162 | SUPPL | 2022-09-27 |
| 72159 | SUPPL | 2022-09-27 |
| 68288 | SUPPL | 2021-08-04 |
| 68285 | SUPPL | 2021-08-04 |
| 62219 | SUPPL | 2020-03-23 |
| 61986 | SUPPL | 2020-02-27 |
| 61951 | SUPPL | 2020-02-25 |
| 47240 | SUPPL | 2017-02-16 |
| 47239 | SUPPL | 2017-02-16 |
| 37342 | SUPPL | 2015-12-17 |
| 5862 | SUPPL | 2015-12-17 |
| 28252 | SUPPL | 2015-02-12 |
| 37341 | SUPPL | 2015-02-10 |
| 15879 | SUPPL | 2013-07-11 |
| 28250 | SUPPL | 2013-07-02 |
| 37340 | SUPPL | 2012-05-01 |
| 37339 | SUPPL | 2012-03-06 |
| 15878 | SUPPL | 2012-03-06 |
| 28251 | SUPPL | 2012-03-05 |
| 28249 | SUPPL | 2012-03-05 |
| 5861 | SUPPL | 2012-03-05 |
| 28248 | SUPPL | 2006-05-01 |
| 5860 | SUPPL | 2006-05-01 |
| 5859 | SUPPL | 2006-05-01 |
| 5857 | SUPPL | 2006-05-01 |
| 42234 | ORIG | 2005-12-05 |
| 44138 | ORIG | 2005-07-29 |
| 5858 | SUPPL | 2005-05-03 |
| 28247 | ORIG | 2004-12-29 |
| 15877 | ORIG | 2004-12-29 |