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 1 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	Golden State Medical Supply, Inc.	5affa0ea-db84-86fd-e063-6294a90a4d16	2026-09-08	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	f7ae2dac-6048-41ea-95d3-cad06cc2baf3	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	American Health Packaging	c751ee54-27b4-4ed7-829a-ced735c41312	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	American Health Packaging	d027f39e-7648-44c8-a8dc-b26b4cdd81be	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Inderal XL	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	ac196ff5-9215-402b-bc57-69aa87f8bade	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
InnoPran XL	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	cd5601b3-4d87-4c3b-acac-b476e787609d	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride ER	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	5415904b-90da-48e8-9f9e-f86749aa129c	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Par Health USA, LLC	0d74bb04-8227-4afa-b523-ce1556150e07	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	52da1afc-7f1c-4893-ab84-8479dd939951	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	86c48c5a-0a59-43a7-b3b5-41ab5da72ce1	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	582fe781-0759-4622-8fa6-b7d90e94e696	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1791ef4d-b609-41c8-b4ef-15bff752ddd7	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d9759182-e681-4c7e-af36-9f7b2184df3c	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
INDERAL LA	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	35d28979-36b1-4630-b85e-a44e0a443734	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Creekwood Pharmaceuticals LLC	289f39f4-ebd3-4fd9-bbb3-72de8124795a	2026-08-21	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	a3bd3ef9-539d-450e-900b-95be0e46095b	2026-08-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	fa5b6189-3419-4134-8bfe-c0d0c77df828	2026-08-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	e3f615e0-07da-491c-9620-7083f4f4318a	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	1cd914b6-b250-4b11-8404-41db3589361e	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	07c3fcab-33fe-4a6a-ba67-2d042190c146	2026-08-04	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.