Application 018553
- Type
- NDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 160MG | Yes | Yes |
| 002 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | Yes | No |
| 003 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | Yes | No |
| 004 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018553-001 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 |
| N018553-002 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 |
| N018553-003 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 |
| N018553-004 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018553-001 | AB |
| N018553-002 | AB |
| N018553-003 | AB |
| N018553-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N018553-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-004 | AB | 1 | d8e5a09893c0… |
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 ER | PROPRANOLOL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 5415904b-90da-48e8-9f9e-f86749aa129c | 2024-08-01 | Warnings, Adverse reactions | 018553 NDA018553 62559-530 62559-533 62559-532 62559-531 |
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 35d28979-36b1-4630-b85e-a44e0a443734 | 2024-08-01 | Warnings, Adverse reactions | 018553 NDA018553 62559-521 62559-522 62559-523 62559-520 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-286 | Propranolol Hydrochloride | propranolol hydrochloride | Blenheim Pharmacal, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43478-900 | Propranolol Hydrochloride | propranolol hydrochloride | Rouses Point Pharm | NDA AUTHORIZED GENERIC | Current |
| 43478-901 | Propranolol Hydrochloride | propranolol hydrochloride | Rouses Point Pharm | NDA AUTHORIZED GENERIC | Current |
| 43478-902 | Propranolol Hydrochloride | propranolol hydrochloride | Rouses Point Pharm | NDA AUTHORIZED GENERIC | Current |
| 43478-903 | Propranolol Hydrochloride | propranolol hydrochloride | Rouses Point Pharm | NDA AUTHORIZED GENERIC | Current |
| 50436-0902 | Propranolol Hydrochloride | propranolol hydrochloride | Unit Dose Services | NDA AUTHORIZED GENERIC | Current |
| 60760-538 | Propranolol Hydrochloride | propranolol hydrochloride | St. Mary's Medical Park Pharmacy | NDA AUTHORIZED GENERIC | Current |
| 61919-488 | Propranolol hcl ER | Propranolol hcl ER | Direct Rx | NDA AUTHORIZED GENERIC | Current |
| 61919-488 | Propranolol hcl ER | Propranolol hcl ER | Direct Rx | NDA AUTHORIZED GENERIC | Current |
| 61919-489 | PROPRANOLOL HYDROCHLORIDE ER | PROPRANOLOL HYDROCHLORIDE ER | Direct Rx | NDA AUTHORIZED GENERIC | Current |
| 61919-489 | PROPRANOLOL HYDROCHLORIDE ER | PROPRANOLOL HYDROCHLORIDE ER | Direct Rx | NDA AUTHORIZED GENERIC | Current |
| 62559-520 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-520 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-520 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-521 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-521 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-521 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-522 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-522 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-522 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-523 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-523 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-523 | INDERAL | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-530 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-530 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-530 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-530 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-530 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-531 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-531 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-531 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-531 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-531 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-532 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-532 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-532 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-532 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-532 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-533 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-533 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-533 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-533 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 62559-533 | Propranolol Hydrochloride | propranolol hydrochloride | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 63629-1968 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-1968 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-7176 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0387 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0387 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0731 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0731 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0731 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0731 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0731 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0907 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0907 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0907 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-0907 | Propranolol Hydrochloride | propranolol hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76535 | SUPPL | 2023-11-08 |
| 76534 | SUPPL | 2023-11-08 |
| 76523 | SUPPL | 2023-11-08 |
| 76522 | SUPPL | 2023-11-08 |
| 942 | SUPPL | 2011-03-23 |
| 11233 | SUPPL | 2011-03-21 |
| 40805 | SUPPL | 2009-09-14 |
| 40804 | SUPPL | 2009-09-14 |
| 40803 | SUPPL | 2009-09-14 |
| 20128 | SUPPL | 2009-09-14 |
| 20127 | SUPPL | 2009-09-14 |
| 15028 | SUPPL | 2007-11-08 |
| 941 | SUPPL | 2007-03-06 |
| 15027 | SUPPL | 2007-01-08 |
| 940 | SUPPL | 2004-06-10 |