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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | ||
| 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… |
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 | Bryant Ranch Prepack | 062a1734-00d1-4871-8e7e-450b0ff5864c | 2024-10-09 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 6a62aad9-94e5-4ac4-8a13-9042c56d4f98 | 2024-10-09 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 2b41246b-dff7-42ca-8591-d6e51e578aa8 | 2024-10-09 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 905e205d-4d0b-4ce0-968e-96171164940e | 2024-10-04 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 89331052-2648-46c6-8d4c-7934ab1ee683 | 2024-10-04 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 3cd58de4-9c48-46a0-a19e-11339ec33aca | 2024-10-04 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 8c681a79-bf2c-4eea-9b81-140ddba00616 | 2024-10-04 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 0e185e88-cea2-4d01-8711-67317247fd25 | 2024-10-04 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 46a32a66-6345-4230-a4f9-dc1a614380c8 | 2024-10-04 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 8b3f61f9-2efc-40c1-9c80-11aa145b3484 | 2024-10-04 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | ea98fedc-c440-487e-b144-35a8a389a446 | 2024-09-06 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | b9d12ace-7e30-4183-99a4-c0a5a6a55cdf | 2024-09-05 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 44a7900c-b240-4e04-954e-2671d4d51ae7 | 2024-08-19 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 92c4bd8f-d0e6-d11a-e053-2995a90a635d | 2024-08-14 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 8e675a00-2b20-4fcd-baa0-661bcf9809c8 | 2024-08-12 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 013a485a-4227-46ae-b19f-c550302fcb96 | 2024-08-09 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 4d24ea79-ba56-44f4-b1a6-e27235176c4a | 2024-08-09 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Lannett Company, Inc. | 5229b561-287b-463c-8679-cda4c34f440b | 2024-07-31 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 933f792f-341f-4d71-e053-2a95a90ad341 | 2024-06-19 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | A-S Medication Solutions | 7b751df5-0751-435b-8755-3d50476cabd2 | 2024-03-05 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.