Application 070178

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	80MG	No	No
002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	60MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070178-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13
A070178-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A070178-001	AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1986-05-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1986-05-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1986-05-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB		1986-05-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2018-04-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A070178-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070178-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070178-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070178-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070178-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070178-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070178-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070178-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070178-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070178-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070178-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070178-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070178-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070178-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070178-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070178-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070178-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070178-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070178-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070178-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070178-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070178-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070178-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070178-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070178-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070178-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A070178-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070178-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A070178-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070178-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A070178-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070178-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070178-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070178-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070178-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070178-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070178-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070178-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070178-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070178-001	AB	1	`ea1830bbd6c7…`

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 brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Ipca Laboratories Limited	9288191e-4d07-4e37-ab66-7b9de9321cf3	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride 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 brand name: Propranolol Hydrochloride 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 brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	96fa108c-b31c-445c-b978-c848cac59419	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	5cf8d0a4-4e02-48f0-8d1f-564357b250c5	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	e0959293-321d-4427-8bb7-8e74b03464d6	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	40333bee-749f-0b43-e063-6394a90a149c	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Actavis Pharma, Inc.	a4edba76-29b8-41fb-bf0b-d4633abba003	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride 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 brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	cd5cf31d-dade-425f-a32c-2e681a008787	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	82a4d30b-5018-453d-a8ab-fef2e3266f69	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	c5ad5449-b93e-4f26-977b-c66466d8ac6f	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Coupler LLC	3e50045f-abdf-3b78-e063-6394a90a4ba0	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	1d79ba59-6346-46c0-8e63-470e2069238e	2025-08-25	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	c139587f-fdfa-4efe-a39e-452f7c39e657	2025-08-25	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	a21eb31b-db50-47a5-8f4c-315c2a842c8b	2025-08-25	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride 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 brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1662	Propranolol Hydrochloride	Propranolol Hydrochloride	Impax Generics	ANDA	Current
0115-1662	Propranolol Hydrochloride	Propranolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0591-5557	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
63629-3587	Propranolol Hydrochloride	Propranolol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-3587	Propranolol Hydrochloride	Propranolol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
70518-0833	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0833	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0833	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0833	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0833	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0833	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2444	Propranolol Hydrochloride	Propranolol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0832	Propranolol Hydrochloride	Propranolol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0832	Propranolol Hydrochloride	Propranolol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0832	Propranolol Hydrochloride	Propranolol Hydrochloride	Bryant Ranch Prepack	ANDA	Current