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 4 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	Northwind Health Company, LLC	f76b7edc-6d7d-9cba-e053-6294a90a035c	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Ipca Laboratories Limited	9288191e-4d07-4e37-ab66-7b9de9321cf3	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol	PROPRANOLOL HYDROCHLORIDE	ProPharma Distribution	45b0aaf0-df6c-7db0-e063-6294a90a9135	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	e289160e-0f3a-4667-b8ba-9c93fbf21a30	2025-12-01	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL	PROPRANOLOL HYDROCHLORIDE	Henry Schein, Inc.	e586996d-9035-4ef4-8c8d-06e70a02577f	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	1aedd4d5-fe70-4cb0-9d6d-d2bd241ebaa6	2025-10-30	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	96fa108c-b31c-445c-b978-c848cac59419	2025-10-30	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	5cf8d0a4-4e02-48f0-8d1f-564357b250c5	2025-10-30	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	e0959293-321d-4427-8bb7-8e74b03464d6	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	40333bee-749f-0b43-e063-6394a90a149c	2025-10-01	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Actavis Pharma, Inc.	a4edba76-29b8-41fb-bf0b-d4633abba003	2025-09-26	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	American Health Packaging	015b5e4f-3228-4259-b419-e0e49694a058	2025-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	cd5cf31d-dade-425f-a32c-2e681a008787	2025-09-19	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	82a4d30b-5018-453d-a8ab-fef2e3266f69	2025-09-11	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	c5ad5449-b93e-4f26-977b-c66466d8ac6f	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Coupler LLC	3e50045f-abdf-3b78-e063-6394a90a4ba0	2025-09-08	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	1d79ba59-6346-46c0-8e63-470e2069238e	2025-08-25	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	c139587f-fdfa-4efe-a39e-452f7c39e657	2025-08-25	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	a21eb31b-db50-47a5-8f4c-315c2a842c8b	2025-08-25	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	62ef3d7d-c87f-4d2f-af12-47d50e8b5488	2025-08-08	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.