Application 071388
- Type
- ANDA
- Sponsor
- ROXANE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | PROPRANOLOL HYDROCHLORIDE | CONCENTRATE;ORAL | 80MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | PROPRANOLOL HYDROCHLORIDE | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 |
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 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A071388-001 | PROPRANOLOL HYDROCHLORIDE INTENSOL | 80MG/ML | CONCENTRATE / ORAL | 1987-05-15 | f41ea6bd6efb… |
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.