Application 019815
- Type
- NDA
- Sponsor
- SHIRE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROAMATINE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | PROAMATINE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | PROAMATINE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N019815-001 | PROAMATINE | MIDODRINE HYDROCHLORIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | |
| N019815-002 | PROAMATINE | MIDODRINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | |
| N019815-003 | PROAMATINE | MIDODRINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 |
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| 2026-08 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019815-002 | PROAMATINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019815-003 | PROAMATINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-03-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019815-001 | PROAMATINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-09-06 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | Bryant Ranch Prepack | 17b24a0b-03e4-4b58-87ab-3d66fec30226 | 2023-10-06 | Warnings, Adverse reactions | MIDODRINE HYDROCHLORIDE |
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | Bryant Ranch Prepack | 60d5a132-9cfc-48e2-aa71-1949aeb255c3 | 2023-04-14 | Boxed warning, Warnings, Adverse reactions | MIDODRINE HYDROCHLORIDE |
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | Bryant Ranch Prepack | 5a6705af-bb72-4edb-863a-93a351bd6dba | 2023-02-27 | Warnings, Adverse reactions | MIDODRINE HYDROCHLORIDE |
| MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 03b54024-2a26-4abe-bd8b-b66bb6781fa7 | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | MIDODRINE HYDROCHLORIDE |
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 32fad00b-7e7b-4d35-9e8b-fdc979fdb88e | 2022-09-29 | Boxed warning, Warnings, Adverse reactions | MIDODRINE HYDROCHLORIDE |
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | Proficient Rx LP | 0aebf5f9-8cfa-4b77-ba40-821ce0a2b266 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | MIDODRINE HYDROCHLORIDE |
| MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | 873c8e29-6961-4648-bfc8-f91c2086bd94 | 2021-10-12 | Boxed warning, Warnings, Adverse reactions | MIDODRINE HYDROCHLORIDE |
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | TruPharma, LLC | a88cd5b5-bdcb-4ef7-8b04-ee4603bcd621 | 2021-01-14 | Boxed warning, Warnings, Adverse reactions | MIDODRINE HYDROCHLORIDE |
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | Bryant Ranch Prepack | 2be17e48-8258-4f29-914b-7f0fe9ace7a1 | 2020-10-16 | Boxed warning, Warnings, Adverse reactions | MIDODRINE HYDROCHLORIDE |
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | Xiromed, LLC | a4332a41-2a0a-a14a-9ce5-1465f39ff725 | 2020-10-15 | Boxed warning, Warnings, Adverse reactions | MIDODRINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.