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 42.

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 · 84 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
2026-08-18 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…`
2022-03-09 01:35 UTC	2022-03	A070178-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1986-05-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070178-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL			2018-04-23	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070178-001	AB	1	`a72a2bbeb626…`

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	REMEDYREPACK INC.	a3bd3ef9-539d-450e-900b-95be0e46095b	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	e3f615e0-07da-491c-9620-7083f4f4318a	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	1cd914b6-b250-4b11-8404-41db3589361e	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	07c3fcab-33fe-4a6a-ba67-2d042190c146	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	49d09308-74b0-4f9a-9c03-37234b5ee3a3	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride 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 brand name: Propranolol Hydrochloride 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 brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	American Health Packaging	c751ee54-27b4-4ed7-829a-ced735c41312	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride 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 brand name: Propranolol Hydrochloride 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 brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	554c7446-8407-460e-b157-f860c5afbf12	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Major Pharmaceuticals	e7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	b609cc7c-1f6a-452b-8ada-c4d2989b83dc	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	4803b5bf-8ca4-4a8b-bd24-1f3ff7d93d7e	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: propranolol hydrochloride 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 brand name: propranolol hydrochloride 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 brand name: Propranolol Hydrochloride 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 brand name: propranolol hydrochloride 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	American Health Packaging	d027f39e-7648-44c8-a8dc-b26b4cdd81be	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Propranolol Hydrochloride 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 brand name: Propranolol Hydrochloride generic name: PROPRANOLOL HYDROCHLORIDE

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