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 5 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	A-S Medication Solutions	be55cf2d-c2f8-4781-b2ef-fd607324265c	2025-08-08	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	179e31a7-9956-4fba-9e9a-2ca28d37d42b	2025-08-04	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	7da73cee-4e98-462d-e053-2991aa0a8bf4	2025-06-16	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Asclemed USA, Inc.	d08dbabc-8ca4-426e-a9fd-e7914a27883c	2025-05-31	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	85973689-bb21-483f-becb-c5c8bfb05658	2025-03-17	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	fc1a2e79-3c3b-4e5a-8e75-0fd7abbac5a0	2025-03-13	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Cardinal Health 107, LLC	74dc9949-010c-4f2c-9aef-63ab466ba657	2025-02-28	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	Direct Rx	d7c0cc12-6d2d-7146-e053-2995a90a85a4	2025-01-21	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	DIRECT RX	a834d1cf-72fc-93bf-e053-2995a90a6191	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ed10dd67-5987-4191-b2d3-9dcf40340caa	2025-01-03	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	29ace768-8fef-482b-e063-6394a90aa2ac	2024-12-19	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	29acc74e-79b5-f668-e063-6394a90aef9b	2024-12-19	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	360de855-b8be-409f-9ca6-d0a0368af174	2024-12-09	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	5ee3776f-9d02-4d98-bc9d-e810c87961c3	2024-11-27	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	1c275a7b-2e85-4990-b3ad-6c675d6c2d7b	2024-10-21	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	b27ade81-8b41-4394-aec1-d23370bfa3b7	2024-10-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	16291f1b-1ce4-480a-a1fc-c20bbac4cbe7	2024-10-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	fce3539f-82f3-4bb5-a6ba-c38171c67c06	2024-10-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	87967c3a-4a6e-45c8-ae3d-1e1dbaa4ba10	2024-10-09	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	d655fb2d-0cfd-4aad-8770-5decdcee10b2	2024-10-09	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.