Application 078494

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No
002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	No	No
003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	No
004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	160MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078494-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10
A078494-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10
A078494-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10
A078494-004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078494-001	AB
A078494-002	AB
A078494-003	AB
A078494-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078494-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078494-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078494-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078494-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078494-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078494-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078494-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078494-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078494-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078494-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078494-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078494-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078494-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078494-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078494-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078494-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078494-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078494-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078494-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078494-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078494-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078494-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078494-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078494-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078494-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078494-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078494-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078494-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078494-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078494-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078494-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078494-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078494-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078494-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078494-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078494-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078494-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078494-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078494-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078494-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-08-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078494-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078494-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078494-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078494-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078494-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078494-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078494-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078494-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078494-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078494-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078494-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078494-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078494-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078494-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078494-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078494-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078494-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078494-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078494-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078494-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078494-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078494-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078494-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078494-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078494-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078494-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078494-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078494-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078494-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078494-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078494-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078494-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078494-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078494-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078494-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078494-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078494-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078494-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078494-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078494-004	AB	1	`d06236e962d9…`

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Actavis Pharma, Inc.	a4edba76-29b8-41fb-bf0b-d4633abba003	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078494 application number: ANDA078494 ndc (product): 0228-2780 ndc (product): 0228-2781 ndc (product): 0228-2778 ndc (product): 0228-2779
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	968353ed-eb79-4f96-9569-3efb220fc388	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078494 application number: ANDA078494
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	e4009ade-155b-4d28-8a8d-555db68bf8b0	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078494 application number: ANDA078494

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2778	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2778	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2778	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2779	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2779	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2779	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2780	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2780	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2780	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2781	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2781	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0228-2781	Propranolol Hydrochloride	Propranolol Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
50090-0420	Propranolol Hydrochloride	Propranolol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0420	Propranolol Hydrochloride	Propranolol Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-4315	Propranolol Hydrochloride	Propranolol Hydrochloride	Unit Dose Services	ANDA	Current
60429-126	Propranolol Hydrochloride	Propranolol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-126	Propranolol Hydrochloride	Propranolol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-127	Propranolol Hydrochloride	Propranolol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-127	Propranolol Hydrochloride	Propranolol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-128	Propranolol Hydrochloride	Propranolol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-128	Propranolol Hydrochloride	Propranolol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-129	Propranolol Hydrochloride	Propranolol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-129	Propranolol Hydrochloride	Propranolol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
68151-3071	Propranolol Hydrochloride	Propranolol Hydrochloride	Carilion Materials Management	ANDA	Current
68788-6855	Propranolol Hydrochloride	Propranolol Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6855	Propranolol Hydrochloride	Propranolol Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6855	Propranolol Hydrochloride	Propranolol Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6855	Propranolol Hydrochloride	Propranolol Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6855	Propranolol Hydrochloride	Propranolol Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70934-257	Propranolol Hydrochloride	Propranolol Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current