Application 070175

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070175-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A070175-001AB

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-133f01610625f2…
2019-09-15 20:21 UTC2019-09A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-13e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A070175-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070175-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070175-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070175-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070175-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070175-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070175-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070175-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070175-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070175-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070175-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070175-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070175-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070175-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070175-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070175-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070175-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070175-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070175-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070175-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070175-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070175-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070175-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070175-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070175-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070175-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070175-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070175-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070175-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070175-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070175-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070175-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070175-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070175-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070175-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070175-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070175-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070175-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070175-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070175-001AB1e64feba35796…

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.

Matched openFDA labels page 1 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.a3bd3ef9-539d-450e-900b-95be0e46095b2026-08-10Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.e3f615e0-07da-491c-9620-7083f4f4318a2026-08-07Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.1cd914b6-b250-4b11-8404-41db3589361e2026-08-05Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.07c3fcab-33fe-4a6a-ba67-2d042190c1462026-08-04Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.49d09308-74b0-4f9a-9c03-37234b5ee3a32026-07-29Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC1df7f35e-b1d8-4aca-875e-d197cb61239e2026-07-29Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions1bb6d65a-8264-4fa4-92d4-c4a756ec49ea2026-07-29Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packagingc751ee54-27b4-4ed7-829a-ced735c413122026-07-20Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.95a2eacd-b6b7-4e92-ae14-52fbee6c65432026-07-20Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC63abab85-ec88-4fcf-a8e7-0850e5f797ee2026-07-20Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.554c7446-8407-460e-b157-f860c5afbf122026-07-14Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEMajor Pharmaceuticalse7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba2026-07-14Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.b609cc7c-1f6a-452b-8ada-c4d2989b83dc2026-07-10Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack4803b5bf-8ca4-4a8b-bd24-1f3ff7d93d7e2026-07-08Warnings, Adverse reactionsName fallback
brand name: propranolol hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy14957737-4e53-cc6d-e063-6294a90a181e2026-06-29Warnings, Adverse reactionsName fallback
brand name: propranolol hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e2026-06-26Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy36230aaa-b6e5-4ebb-e063-6294a90ac3b92026-06-25Warnings, Adverse reactionsName fallback
brand name: propranolol hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
HEMANGEOLPROPRANOLOL HYDROCHLORIDEPierre Fabre Pharmaceuticals, Inc.b6f9dd2a-632b-87eb-70f0-b2064d7ed48a2026-06-25Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packagingd027f39e-7648-44c8-a8dc-b26b4cdd81be2026-06-23Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLC03afbc5a-a9dc-e823-e063-6394a90a0cb22026-06-23Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1659Propranolol HydrochloridePropranolol HydrochlorideImpax GenericsANDACurrent
0115-1659Propranolol HydrochloridePropranolol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0591-5554Propranolol HydrochloridePropranolol HydrochlorideActavis Pharma, Inc.ANDACurrent
0615-8186Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8186Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8186Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8186Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8186Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8186Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
50268-700Propranolol HydrochloridePropranolol HydrochlorideAvPAKANDACurrent
50268-700Propranolol HydrochloridePropranolol HydrochlorideAvPAKANDACurrent
50268-700Propranolol HydrochloridePropranolol HydrochlorideAvPAKANDACurrent
53002-4560Propranolol HydrochloridePropranolol HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4560Propranolol HydrochloridePropranolol HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4561Propranolol HydrochloridePropranolol HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
63629-6934Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent
68151-2013Propranolol HydrochloridePropranolol HydrochlorideCarilion Materials ManagementANDACurrent
70518-0309Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0309Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0309Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0309Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0309Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1041Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1041Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1041Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1041Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1041Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
71205-185Propranolol HydrochloridePropranolol HydrochlorideProficient Rx LPANDACurrent
71205-185Propranolol HydrochloridePropranolol HydrochlorideProficient Rx LPANDACurrent
71205-499Propranolol HydrochloridePropranolol HydrochlorideProficient Rx LPANDACurrent
71205-499Propranolol HydrochloridePropranolol HydrochlorideProficient Rx LPANDACurrent
71335-1140Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent
71335-1140Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent
71335-1140Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent
71335-1140Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent
71335-1140Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent