Application 016418
- Type
- NDA
- Sponsor
- WYETH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 009 | INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 010 | INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N016418-001 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N016418-002 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N016418-003 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N016418-004 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N016418-009 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | |
| N016418-010 | INDERAL | PROPRANOLOL HYDROCHLORIDE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016418-009 | INDERAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016418-010 | INDERAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016418-001 | INDERAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016418-002 | INDERAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016418-003 | INDERAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016418-004 | INDERAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016418-009 | INDERAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016418-010 | INDERAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016418-001 | INDERAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016418-002 | INDERAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016418-003 | INDERAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016418-004 | INDERAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016418-009 | INDERAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016418-010 | INDERAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016418-001 | INDERAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016418-002 | INDERAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016418-003 | INDERAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016418-004 | INDERAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016418-009 | INDERAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016418-010 | INDERAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016418-001 | INDERAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016418-002 | INDERAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016418-003 | INDERAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016418-004 | INDERAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016418-009 | INDERAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016418-010 | INDERAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016418-001 | INDERAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016418-002 | INDERAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016418-003 | INDERAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016418-004 | INDERAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016418-009 | INDERAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016418-010 | INDERAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N016418-001 | INDERAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016418-002 | INDERAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016418-003 | INDERAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016418-004 | INDERAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016418-009 | INDERAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N016418-010 | INDERAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-10-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016418-001 | INDERAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016418-002 | INDERAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Golden State Medical Supply, Inc. | 5affa0ea-db84-86fd-e063-6294a90a4d16 | 2026-09-08 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | f7ae2dac-6048-41ea-95d3-cad06cc2baf3 | 2026-09-03 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | American Health Packaging | c751ee54-27b4-4ed7-829a-ced735c41312 | 2026-09-02 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | American Health Packaging | d027f39e-7648-44c8-a8dc-b26b4cdd81be | 2026-09-02 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Inderal XL | PROPRANOLOL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | ac196ff5-9215-402b-bc57-69aa87f8bade | 2026-08-27 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| InnoPran XL | PROPRANOLOL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | cd5601b3-4d87-4c3b-acac-b476e787609d | 2026-08-27 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride ER | PROPRANOLOL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 5415904b-90da-48e8-9f9e-f86749aa129c | 2026-08-27 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Par Health USA, LLC | 0d74bb04-8227-4afa-b523-ce1556150e07 | 2026-08-26 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 52da1afc-7f1c-4893-ab84-8479dd939951 | 2026-08-24 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 1791ef4d-b609-41c8-b4ef-15bff752ddd7 | 2026-08-24 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | d9759182-e681-4c7e-af36-9f7b2184df3c | 2026-08-24 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 35d28979-36b1-4630-b85e-a44e0a443734 | 2026-08-24 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Creekwood Pharmaceuticals LLC | 289f39f4-ebd3-4fd9-bbb3-72de8124795a | 2026-08-21 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | a3bd3ef9-539d-450e-900b-95be0e46095b | 2026-08-10 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | fa5b6189-3419-4134-8bfe-c0d0c77df828 | 2026-08-10 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | e3f615e0-07da-491c-9620-7083f4f4318a | 2026-08-07 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | 1cd914b6-b250-4b11-8404-41db3589361e | 2026-08-05 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | 07c3fcab-33fe-4a6a-ba67-2d042190c146 | 2026-08-04 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 49d09308-74b0-4f9a-9c03-37234b5ee3a3 | 2026-07-29 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Cardinal Health 107, LLC | 1df7f35e-b1d8-4aca-875e-d197cb61239e | 2026-07-29 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.