Application 071972

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL10MGNoNo
002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL20MGNoNo
003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL40MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071972-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06
A071972-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06
A071972-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A071972-001AB
A071972-002AB
A071972-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-061e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071972-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071972-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071972-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071972-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071972-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071972-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071972-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071972-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071972-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071972-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071972-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071972-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071972-001AB11e350fbaab3a…

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.a3bd3ef9-539d-450e-900b-95be0e46095b2026-08-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
ndc (product): 70518-3466
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.e3f615e0-07da-491c-9620-7083f4f4318a2026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
ndc (product): 70518-3377
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.1cd914b6-b250-4b11-8404-41db3589361e2026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
ndc (product): 70518-3281
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.49d09308-74b0-4f9a-9c03-37234b5ee3a32026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.95a2eacd-b6b7-4e92-ae14-52fbee6c65432026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEMajor Pharmaceuticalse7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLC03afbc5a-a9dc-e823-e063-6394a90a0cb22026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy42def694-9484-a2ca-e063-6394a90a87d82026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECoupler LLC53e65732-3acf-597a-e063-6294a90a31912026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmneal Pharmaceuticals NY LLC14d0c95d-418f-40a8-bad3-e20c824249602026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
ndc (product): 69238-2079
ndc (product): 69238-2078
ndc (product): 69238-2077
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAvPAK039b415b-094a-da37-e063-6294a90a52d72026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLCf2b68e23-2a9d-76b4-e053-2995a90a375a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLCf76b7edc-6d7d-9cba-e053-6294a90a035c2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.d9759182-e681-4c7e-af36-9f7b2184df3c2025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.1791ef4d-b609-41c8-b4ef-15bff752ddd72025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack1d79ba59-6346-46c0-8e63-470e2069238e2025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackc139587f-fdfa-4efe-a39e-452f7c39e6572025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepacka21eb31b-db50-47a5-8f4c-315c2a842c8b2025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC74dc9949-010c-4f2c-9aef-63ab466ba6572025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29acc74e-79b5-f668-e063-6394a90aef9b2024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7761Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8413Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8413Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8417Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8426Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
50111-467Propranolol HydrochloridePropranolol HydrochlorideTeva Pharmaceuticals USA,ANDACurrent
55700-315Propranolol HydrochloridePropranolol HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
63629-6310Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent
69238-2077Propranolol HydrochloridePropranolol HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-2077Propranolol HydrochloridePropranolol HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-2078Propranolol HydrochloridePropranolol HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-2078Propranolol HydrochloridePropranolol HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-2079Propranolol HydrochloridePropranolol HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-2079Propranolol HydrochloridePropranolol HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
70518-3281Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3281Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3377Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3377Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3377Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3466Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3466Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0463Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent