Application 071388

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPRANOLOL HYDROCHLORIDE INTENSOL	PROPRANOLOL HYDROCHLORIDE	CONCENTRATE;ORAL	80MG/ML	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	PROPRANOLOL HYDROCHLORIDE	80MG/ML	CONCENTRATE / ORAL			1987-05-15

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071388-001	PROPRANOLOL HYDROCHLORIDE INTENSOL	80MG/ML	CONCENTRATE / ORAL	1987-05-15	`f41ea6bd6efb…`

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 3 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	4dd23053-0458-40f2-ac34-afb8cc9903aa	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	8cbac6dc-ef1d-6662-e053-2995a90af13f	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	414c4b69-38a1-4220-bec8-204c9a624b85	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	f70e5e97-a045-4d22-8da5-be4b7eb77530	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	9390cfd6-b2e0-48ad-8c4d-ed63cf6b923a	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8bdb15bc-5a25-4f20-af98-79bcd26022b8	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	8f31a40c-7c79-457b-af6e-d945e4807cff	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	AvKARE	753ab3cb-e7ee-424b-aa7d-195b5871a40e	2026-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4a2b8d97-b89b-6b68-e063-6394a90ab332	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Coupler LLC	4a006e05-b8c3-236c-e063-6294a90abf26	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Lifestar Pharma LLC	25f9b9a3-7b0b-48d2-a458-c613bedc7cab	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	7da9bb37-cc22-4eff-8de0-429f64cb599e	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	e0241448-5727-4c68-ae2a-6f41cd962d7c	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	b94dcec7-7633-4a33-9cea-48161adeaf93	2026-01-15	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	91f2ff1d-68d8-4e83-a2db-618f0410ead7	2026-01-12	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	AvPAK	039b415b-094a-da37-e063-6294a90a52d7	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Northwind Health Company, LLC	f2b68e23-2a9d-76b4-e053-2995a90a375a	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Northwind Health Company, LLC	f2b8b894-d887-c4ee-e053-2995a90a0c0b	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Northwind Health Company, LLC	c29d733a-4fcb-6564-e053-2995a90ae541	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Northwind Health Company, LLC	da804f70-9558-6e85-e053-2a95a90a9079	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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