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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A070175-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1986-05-1384e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A070175-001AB184e616aacf4f…
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…

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 6 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack062a1734-00d1-4871-8e7e-450b0ff5864c2024-10-09Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack6a62aad9-94e5-4ac4-8a13-9042c56d4f982024-10-09Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack2b41246b-dff7-42ca-8591-d6e51e578aa82024-10-09Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack905e205d-4d0b-4ce0-968e-96171164940e2024-10-04Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack89331052-2648-46c6-8d4c-7934ab1ee6832024-10-04Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack3cd58de4-9c48-46a0-a19e-11339ec33aca2024-10-04Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack8c681a79-bf2c-4eea-9b81-140ddba006162024-10-04Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack0e185e88-cea2-4d01-8711-67317247fd252024-10-04Warnings, Adverse reactionsName fallback
brand name: propranolol hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack46a32a66-6345-4230-a4f9-dc1a614380c82024-10-04Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack8b3f61f9-2efc-40c1-9c80-11aa145b34842024-10-04Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackea98fedc-c440-487e-b144-35a8a389a4462024-09-06Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackb9d12ace-7e30-4183-99a4-c0a5a6a55cdf2024-09-05Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack44a7900c-b240-4e04-954e-2671d4d51ae72024-08-19Warnings, Adverse reactionsName fallback
brand name: propranolol hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.92c4bd8f-d0e6-d11a-e053-2995a90a635d2024-08-14Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack8e675a00-2b20-4fcd-baa0-661bcf9809c82024-08-12Warnings, Adverse reactionsName fallback
brand name: propranolol hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs013a485a-4227-46ae-b19f-c550302fcb962024-08-09Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs4d24ea79-ba56-44f4-b1a6-e27235176c4a2024-08-09Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDELannett Company, Inc.5229b561-287b-463c-8679-cda4c34f440b2024-07-31Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.933f792f-341f-4d71-e053-2a95a90ad3412024-06-19Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions7b751df5-0751-435b-8755-3d50476cabd22024-03-05Warnings, Adverse reactionsName fallback
brand name: Propranolol Hydrochloride
generic name: PROPRANOLOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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