Application 071972

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	20MG	No	No
003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A071972-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06
A071972-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06
A071972-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06

Therapeutic equivalence codes#

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

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

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A071972-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071972-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071972-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071972-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071972-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071972-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071972-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071972-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071972-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071972-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071972-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071972-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071972-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071972-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071972-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071972-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071972-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071972-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071972-001	AB	1	`301d65b070ca…`

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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	013a485a-4227-46ae-b19f-c550302fcb96	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071972 application number: ANDA071972 ndc (product): 0615-8413 ndc (product): 0615-8417
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	4d24ea79-ba56-44f4-b1a6-e27235176c4a	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071972 application number: ANDA071972 ndc (product): 0615-8426
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	7b751df5-0751-435b-8755-3d50476cabd2	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071972 application number: ANDA071972
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	325dda2c-ecd9-4368-8779-7ff505b2b138	2024-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071972 application number: ANDA071972
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	d1110a10-a7f4-4295-9e94-8fbb56f77f67	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071972 application number: ANDA071972

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7761	Propranolol Hydrochloride	Propranolol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8413	Propranolol Hydrochloride	Propranolol Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8413	Propranolol Hydrochloride	Propranolol Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8417	Propranolol Hydrochloride	Propranolol Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8426	Propranolol Hydrochloride	Propranolol Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
50111-467	Propranolol Hydrochloride	Propranolol Hydrochloride	Teva Pharmaceuticals USA,	ANDA	Current
55700-315	Propranolol Hydrochloride	Propranolol Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63629-6310	Propranolol Hydrochloride	Propranolol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
69238-2077	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-2077	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-2078	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-2078	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-2079	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-2079	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
70518-3281	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3281	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3377	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3377	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3377	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3466	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3466	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0463	Propranolol Hydrochloride	Propranolol Hydrochloride	Bryant Ranch Prepack	ANDA	Current