Application 070175
- Type
- ANDA
- Sponsor
- WATSON LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A070175-001 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A070175-001 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A070175-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1986-05-13 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A070175-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A070175-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070175-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A070175-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070175-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070175-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070175-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070175-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070175-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070175-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A070175-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070175-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070175-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070175-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A070175-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070175-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A070175-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A070175-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A070175-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A070175-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A070175-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070175-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A070175-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A070175-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A070175-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A070175-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A070175-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A070175-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070175-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A070175-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A070175-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070175-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070175-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070175-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070175-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A070175-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A070175-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070175-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A070175-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A070175-001 | AB | 1 | e64feba35796… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1659 | Propranolol Hydrochloride | Propranolol Hydrochloride | Impax Generics | ANDA | Current |
| 0115-1659 | Propranolol Hydrochloride | Propranolol Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0591-5554 | Propranolol Hydrochloride | Propranolol Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0615-8186 | Propranolol Hydrochloride | Propranolol Hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8186 | Propranolol Hydrochloride | Propranolol Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8186 | Propranolol Hydrochloride | Propranolol Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8186 | Propranolol Hydrochloride | Propranolol Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8186 | Propranolol Hydrochloride | Propranolol Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8186 | Propranolol Hydrochloride | Propranolol Hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 50268-700 | Propranolol Hydrochloride | Propranolol Hydrochloride | AvPAK | ANDA | Current |
| 50268-700 | Propranolol Hydrochloride | Propranolol Hydrochloride | AvPAK | ANDA | Current |
| 50268-700 | Propranolol Hydrochloride | Propranolol Hydrochloride | AvPAK | ANDA | Current |
| 53002-4560 | Propranolol Hydrochloride | Propranolol Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-4560 | Propranolol Hydrochloride | Propranolol Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-4561 | Propranolol Hydrochloride | Propranolol Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 63629-6934 | Propranolol Hydrochloride | Propranolol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68151-2013 | Propranolol Hydrochloride | Propranolol Hydrochloride | Carilion Materials Management | ANDA | Current |
| 70518-0309 | Propranolol Hydrochloride | Propranolol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0309 | Propranolol Hydrochloride | Propranolol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0309 | Propranolol Hydrochloride | Propranolol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0309 | Propranolol Hydrochloride | Propranolol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0309 | Propranolol Hydrochloride | Propranolol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1041 | Propranolol Hydrochloride | Propranolol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1041 | Propranolol Hydrochloride | Propranolol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1041 | Propranolol Hydrochloride | Propranolol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1041 | Propranolol Hydrochloride | Propranolol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1041 | Propranolol Hydrochloride | Propranolol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71205-185 | Propranolol Hydrochloride | Propranolol Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-185 | Propranolol Hydrochloride | Propranolol Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-499 | Propranolol Hydrochloride | Propranolol Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-499 | Propranolol Hydrochloride | Propranolol Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-1140 | Propranolol Hydrochloride | Propranolol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1140 | Propranolol Hydrochloride | Propranolol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1140 | Propranolol Hydrochloride | Propranolol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1140 | Propranolol Hydrochloride | Propranolol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1140 | Propranolol Hydrochloride | Propranolol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |