Application 008848
- Type
- NDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PAMINE | METHSCOPOLAMINE BROMIDE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | PAMINE FORTE | METHSCOPOLAMINE BROMIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N008848-001 | PAMINE | METHSCOPOLAMINE BROMIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | ||
| N008848-002 | PAMINE FORTE | METHSCOPOLAMINE BROMIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 |
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UTC | 2026-02 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N008848-001 | PAMINE | 2.5MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N008848-002 | PAMINE FORTE | 5MG | TABLET / ORAL | 2003-03-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N008848-001 | PAMINE | 2.5MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N008848-002 | PAMINE FORTE | 5MG | TABLET / ORAL | 2003-03-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2003-03-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2003-03-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N008848-001 | PAMINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N008848-002 | PAMINE FORTE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2003-03-25 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | Bryant Ranch Prepack | 4ee28ed4-daff-462c-a38b-4fd8250ed9f4 | 2026-06-30 | Warnings, Adverse reactions | METHSCOPOLAMINE BROMIDE |
| METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | Bryant Ranch Prepack | 6b8ed187-d378-4c95-80e0-0d3558a7aa95 | 2026-03-13 | Warnings, Adverse reactions | METHSCOPOLAMINE BROMIDE |
| METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | PD-Rx Pharmaceuticals, Inc. | 26cd56db-4727-40d1-8f08-3ee899052c77 | 2026-01-05 | Warnings, Adverse reactions | METHSCOPOLAMINE BROMIDE |
| METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | PD-Rx Pharmaceuticals, Inc. | 8a14ade6-d428-4144-9037-46955f68820f | 2026-01-05 | Warnings, Adverse reactions | METHSCOPOLAMINE BROMIDE |
| METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | Unichem Pharmaceuticals (USA), Inc. | 5c74bfb0-c80a-4a86-acd1-1e3a1b20255d | 2025-12-10 | Warnings, Adverse reactions | METHSCOPOLAMINE BROMIDE |
| METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | i3 Pharmaceuticals, LLC | 14c0c030-e96d-4a5e-95ff-02dd78a46be3 | 2025-02-24 | Warnings, Adverse reactions | METHSCOPOLAMINE BROMIDE |
| Methscopolamine Bromide | METHSCOPOLAMINE BROMIDE | Breckenridge Pharmaceutical, Inc. | 157c1cce-bceb-4c74-8aa0-d2be9952d8f9 | 2024-01-10 | Warnings, Adverse reactions | METHSCOPOLAMINE BROMIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0482 | Methscopolamine Bromide | methscopolamine bromide | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0168-0483 | Methscopolamine Bromide | methscopolamine bromide | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 10337-061 | Pamine | methscopolamine bromide | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 10337-062 | Pamine Forte | methscopolamine bromide | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |