Application 070516

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	10MG	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
A070516-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL			1986-07-07

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	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070516-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1986-07-07	`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 7 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	325dda2c-ecd9-4368-8779-7ff505b2b138	2024-03-03	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df61a348-0fe9-71c0-e053-2a95a90a9a4c	2024-02-28	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	d1110a10-a7f4-4295-9e94-8fbb56f77f67	2024-02-27	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	11873816-5789-e951-e063-6294a90ad16e	2024-02-16	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	1d7c1de3-3cf4-4b1e-bdcc-55f423c88001	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	d1cfdb57-0b04-43f7-bd10-c585f77385b3	2023-08-09	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	693569bd-6053-5b3e-e053-2a91aa0a6e9c	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol	PROPRANOLOL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e50d1ee-b7f3-e549-e053-2995a90a4a86	2023-05-09	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	cf393c74-381f-4b60-8479-b0763bc71e8e	2023-04-03	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	91055555-6967-4b6a-b5c8-5211ec18d2c8	2023-04-01	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	968353ed-eb79-4f96-9569-3efb220fc388	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	e4009ade-155b-4d28-8a8d-555db68bf8b0	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	AMICI PHARMACEUTICALS LLC	8efc9fc6-6db0-43c9-892b-7423a9ba679f	2023-01-24	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol	PROPRANOLOL HYDROCHLORIDE	Fresenius Kabi USA, LLC	f14ea537-dd5c-4c78-9037-9a85e9e610ef	2023-01-12	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	ec9e45ed-4c62-4075-b40e-2a9e40ac682b	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb	2022-06-22	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	ea86beb4-33c8-4841-a742-82212ce716d2	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3c05ab1f-05b0-494a-b640-667e7cf517a1	2021-07-01	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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