Application 078489

Type: ANDA
Sponsor: HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALPRAZOLAM	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	0.5MG	No	No
002	ALPRAZOLAM	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	1MG	No	No
003	ALPRAZOLAM	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	2MG	No	No
004	ALPRAZOLAM	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	3MG	No	No

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

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	Approval date
A078489-001	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17
A078489-002	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17
A078489-003	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17
A078489-004	ALPRAZOLAM	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17

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 · 172 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	A078489-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078489-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078489-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078489-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078489-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078489-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078489-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078489-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078489-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078489-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078489-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078489-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078489-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078489-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078489-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078489-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078489-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078489-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078489-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078489-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078489-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078489-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078489-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078489-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078489-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078489-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078489-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078489-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078489-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078489-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078489-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078489-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078489-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078489-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078489-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078489-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078489-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078489-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078489-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078489-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2008-10-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078489-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078489-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078489-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078489-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078489-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078489-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078489-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078489-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078489-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078489-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078489-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078489-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078489-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078489-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078489-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078489-004	AB	1	`ea99ee380514…`

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 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	Northwind Health Company, LLC	25174ee5-a86e-ab97-e063-6394a90acd87	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Aurobindo Pharma Limited	d2fd0b3e-9b78-44d0-82a6-96d6c6238750	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Aurobindo Pharma Limited	326fa31a-5420-429b-9f7f-170cb38f64bd	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	5040e1ed-32d6-4757-a0ee-b8240f3e7cf5	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	2f16ff78-1262-4bb8-9a25-822c13c4746f	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	AvPAK	3fa14fa4-45a7-6ef4-e063-6394a90a1dcd	2025-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	A-S Medication Solutions	3c0cb60f-1c3a-48a6-ad16-f14351548412	2025-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals, Inc.	315b5782-969a-4324-e063-6394a90acf37	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals, Inc.	315b8cf2-01a0-3f7d-e063-6394a90a39b5	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	0ffcdbab-17e4-4395-8155-5b6ad00be6c2	2025-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam XR	ALPRAZOLAM	Mylan Pharmaceuticals Inc.	1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Direct_Rx	f77cfdd0-847d-4edd-e053-6394a90a91b7	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Mylan Pharmaceuticals Inc.	13930c94-d83a-414f-be35-b1fef35f738d	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	02840ea6-e4a0-96a0-e063-6394a90a19ae	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	b39e2bc8-b68f-0f4e-e053-2995a90a00fd	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	b4cd647f-1ba3-334e-e053-2995a90af352	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	f667458d-ddda-4e9e-e053-2995a90adb5a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	American Health Packaging	ea95d182-453b-4c43-8402-d65c488d55f2	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	26f8b63c-6dad-8fac-e063-6394a90a5435	2024-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM

Reported adverse events (FAERS/openFDA)#

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