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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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 | 4dd23053-0458-40f2-ac34-afb8cc9903aa | 2026-05-27 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Golden State Medical Supply, Inc. | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 2026-04-15 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | 414c4b69-38a1-4220-bec8-204c9a624b85 | 2026-04-13 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | f70e5e97-a045-4d22-8da5-be4b7eb77530 | 2026-03-30 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | 9390cfd6-b2e0-48ad-8c4d-ed63cf6b923a | 2026-03-19 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 8bdb15bc-5a25-4f20-af98-79bcd26022b8 | 2026-03-17 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 8f31a40c-7c79-457b-af6e-d945e4807cff | 2026-03-13 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | AvKARE | 753ab3cb-e7ee-424b-aa7d-195b5871a40e | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4a2b8d97-b89b-6b68-e063-6394a90ab332 | 2026-02-06 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Coupler LLC | 4a006e05-b8c3-236c-e063-6294a90abf26 | 2026-02-04 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Lifestar Pharma LLC | 25f9b9a3-7b0b-48d2-a458-c613bedc7cab | 2026-02-02 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 7da9bb37-cc22-4eff-8de0-429f64cb599e | 2026-01-22 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | e0241448-5727-4c68-ae2a-6f41cd962d7c | 2026-01-22 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | b94dcec7-7633-4a33-9cea-48161adeaf93 | 2026-01-15 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 91f2ff1d-68d8-4e83-a2db-618f0410ead7 | 2026-01-12 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | AvPAK | 039b415b-094a-da37-e063-6294a90a52d7 | 2026-01-09 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Northwind Health Company, LLC | f2b68e23-2a9d-76b4-e053-2995a90a375a | 2026-01-01 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Northwind Health Company, LLC | f2b8b894-d887-c4ee-e053-2995a90a0c0b | 2026-01-01 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Northwind Health Company, LLC | c29d733a-4fcb-6564-e053-2995a90ae541 | 2026-01-01 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Northwind Health Company, LLC | da804f70-9558-6e85-e053-2a95a90a9079 | 2026-01-01 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.