Application 078703
- Type
- ANDA
- Sponsor
- ADARE PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 002 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | No | No |
| 003 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | No | No |
| 004 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 160MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078703-001 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | |
| A078703-002 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | |
| A078703-003 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | |
| A078703-004 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078703-001 | AB |
| A078703-002 | AB |
| A078703-003 | AB |
| A078703-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078703-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-004 | AB | 1 | d06236e962d9… |
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 | 4803b5bf-8ca4-4a8b-bd24-1f3ff7d93d7e | 2026-07-08 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 14957737-4e53-cc6d-e063-6294a90a181e | 2026-06-29 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 36230aaa-b6e5-4ebb-e063-6294a90ac3b9 | 2026-06-25 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | AvKARE | 753ab3cb-e7ee-424b-aa7d-195b5871a40e | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | 078703 ANDA078703 42291-524 42291-523 42291-522 42291-525 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | e0241448-5727-4c68-ae2a-6f41cd962d7c | 2026-01-22 | Warnings, Adverse reactions | 078703 ANDA078703 70518-1463 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 1aedd4d5-fe70-4cb0-9d6d-d2bd241ebaa6 | 2025-10-30 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 96fa108c-b31c-445c-b978-c848cac59419 | 2025-10-30 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 5cf8d0a4-4e02-48f0-8d1f-564357b250c5 | 2025-10-30 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | e0959293-321d-4427-8bb7-8e74b03464d6 | 2025-10-13 | Warnings, Adverse reactions | 078703 ANDA078703 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | American Health Packaging | 015b5e4f-3228-4259-b419-e0e49694a058 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 078703 ANDA078703 60687-215 60687-226 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 82a4d30b-5018-453d-a8ab-fef2e3266f69 | 2025-09-11 | Warnings, Adverse reactions | 078703 ANDA078703 71335-0234 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | c5ad5449-b93e-4f26-977b-c66466d8ac6f | 2025-09-10 | Warnings, Adverse reactions | 078703 ANDA078703 63629-9282 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | 179e31a7-9956-4fba-9e9a-2ca28d37d42b | 2025-08-04 | Warnings, Adverse reactions | 078703 ANDA078703 51991-817 51991-820 51991-818 51991-819 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 5ee3776f-9d02-4d98-bc9d-e810c87961c3 | 2024-11-27 | Warnings, Adverse reactions | 078703 ANDA078703 63629-2072 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 0e185e88-cea2-4d01-8711-67317247fd25 | 2024-10-04 | Warnings, Adverse reactions | 078703 ANDA078703 63629-2069 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 44a7900c-b240-4e04-954e-2671d4d51ae7 | 2024-08-19 | Warnings, Adverse reactions | 078703 ANDA078703 63629-2070 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 8e675a00-2b20-4fcd-baa0-661bcf9809c8 | 2024-08-12 | Warnings, Adverse reactions | 078703 ANDA078703 63629-2071 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Proficient Rx LP | 1d7c1de3-3cf4-4b1e-bdcc-55f423c88001 | 2024-02-01 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | A-S Medication Solutions | d1cfdb57-0b04-43f7-bd10-c585f77385b3 | 2023-08-09 | Warnings, Adverse reactions | 078703 ANDA078703 50090-1501 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-522 | propranolol hydrochloride | propranolol hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-522 | propranolol hydrochloride | propranolol hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-522 | propranolol hydrochloride | propranolol hydrochloride | AvKARE | ANDA | Current |
| 42291-523 | propranolol hydrochloride | propranolol hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-523 | propranolol hydrochloride | propranolol hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-523 | propranolol hydrochloride | propranolol hydrochloride | AvKARE | ANDA | Current |
| 42291-524 | propranolol hydrochloride | propranolol hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-524 | propranolol hydrochloride | propranolol hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-524 | propranolol hydrochloride | propranolol hydrochloride | AvKARE | ANDA | Current |
| 42291-525 | propranolol hydrochloride | propranolol hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-525 | propranolol hydrochloride | propranolol hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-525 | propranolol hydrochloride | propranolol hydrochloride | AvKARE | ANDA | Current |
| 50090-1501 | propranolol hydrochloride | propranolol hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1501 | propranolol hydrochloride | propranolol hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1501 | propranolol hydrochloride | propranolol hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51991-817 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-817 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-817 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-818 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-818 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-818 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-819 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-819 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-819 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-820 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-820 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-820 | propranolol hydrochloride | propranolol hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 55700-121 | propranolol hydrochloride | propranolol hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-940 | propranolol hydrochloride | propranolol hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-940 | propranolol hydrochloride | propranolol hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 60687-215 | Propranolol Hydrochloride | Propranolol Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-215 | Propranolol Hydrochloride | Propranolol Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-215 | Propranolol Hydrochloride | Propranolol Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-226 | Propranolol Hydrochloride | Propranolol Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-226 | Propranolol Hydrochloride | Propranolol Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-226 | Propranolol Hydrochloride | Propranolol Hydrochloride | American Health Packaging | ANDA | Current |
| 61919-794 | Propranolol HCL ER | Propranolol HCL ER | Direct Rx | ANDA | Current |
| 63629-2069 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2069 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2070 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2070 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2071 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2071 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2072 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2072 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-9282 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 70518-1463 | propranolol hydrochloride | propranolol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1463 | propranolol hydrochloride | propranolol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1463 | propranolol hydrochloride | propranolol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1463 | propranolol hydrochloride | propranolol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1463 | propranolol hydrochloride | propranolol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1654 | propranolol hydrochloride | propranolol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1654 | propranolol hydrochloride | propranolol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1654 | propranolol hydrochloride | propranolol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1831 | propranolol hydrochloride | propranolol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0234 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0234 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0234 | propranolol hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72189-018 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | Direct_Rx | ANDA | Current |