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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| INDERAL | PROPRANOLOL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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 | A-S Medication Solutions | be55cf2d-c2f8-4781-b2ef-fd607324265c | 2025-08-08 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | 179e31a7-9956-4fba-9e9a-2ca28d37d42b | 2025-08-04 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 7da73cee-4e98-462d-e053-2991aa0a8bf4 | 2025-06-16 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Asclemed USA, Inc. | d08dbabc-8ca4-426e-a9fd-e7914a27883c | 2025-05-31 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 85973689-bb21-483f-becb-c5c8bfb05658 | 2025-03-17 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | fc1a2e79-3c3b-4e5a-8e75-0fd7abbac5a0 | 2025-03-13 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Cardinal Health 107, LLC | 74dc9949-010c-4f2c-9aef-63ab466ba657 | 2025-02-28 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | Direct Rx | d7c0cc12-6d2d-7146-e053-2995a90a85a4 | 2025-01-21 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | DIRECT RX | a834d1cf-72fc-93bf-e053-2995a90a6191 | 2025-01-17 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ed10dd67-5987-4191-b2d3-9dcf40340caa | 2025-01-03 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 29ace768-8fef-482b-e063-6394a90aa2ac | 2024-12-19 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 29acc74e-79b5-f668-e063-6394a90aef9b | 2024-12-19 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 360de855-b8be-409f-9ca6-d0a0368af174 | 2024-12-09 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 5ee3776f-9d02-4d98-bc9d-e810c87961c3 | 2024-11-27 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 1c275a7b-2e85-4990-b3ad-6c675d6c2d7b | 2024-10-21 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | b27ade81-8b41-4394-aec1-d23370bfa3b7 | 2024-10-10 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 16291f1b-1ce4-480a-a1fc-c20bbac4cbe7 | 2024-10-10 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | fce3539f-82f3-4bb5-a6ba-c38171c67c06 | 2024-10-10 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | A-S Medication Solutions | 87967c3a-4a6e-45c8-ae3d-1e1dbaa4ba10 | 2024-10-09 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | d655fb2d-0cfd-4aad-8770-5decdcee10b2 | 2024-10-09 | Warnings, Adverse reactions | PROPRANOLOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.