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 2 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	PD-Rx Pharmaceuticals, Inc.	49d09308-74b0-4f9a-9c03-37234b5ee3a3	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Cardinal Health 107, LLC	1df7f35e-b1d8-4aca-875e-d197cb61239e	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	1bb6d65a-8264-4fa4-92d4-c4a756ec49ea	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	95a2eacd-b6b7-4e92-ae14-52fbee6c6543	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Cardinal Health 107, LLC	63abab85-ec88-4fcf-a8e7-0850e5f797ee	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	554c7446-8407-460e-b157-f860c5afbf12	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Major Pharmaceuticals	e7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	b609cc7c-1f6a-452b-8ada-c4d2989b83dc	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	4803b5bf-8ca4-4a8b-bd24-1f3ff7d93d7e	2026-07-08	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	14957737-4e53-cc6d-e063-6294a90a181e	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	36230aaa-b6e5-4ebb-e063-6294a90ac3b9	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
HEMANGEOL	PROPRANOLOL HYDROCHLORIDE	Pierre Fabre Pharmaceuticals, Inc.	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Northwind Health Company, LLC	03afbc5a-a9dc-e823-e063-6394a90a0cb2	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	42def694-9484-a2ca-e063-6394a90a87d8	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	54154f18-2f15-d247-e063-6294a90a7412	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2c9a6403-5ebf-4348-be02-7ffad5832369	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Coupler LLC	53e65732-3acf-597a-e063-6294a90a3191	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	c01fc93e-cff2-50d5-e053-2a95a90a1897	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	14d0c95d-418f-40a8-bad3-e20c82424960	2026-06-10	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.