Application 078088

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALPRAZOLAM	ALPRAZOLAM	TABLET, ORALLY DISINTEGRATING;ORAL	0.25MG	No	No
002	ALPRAZOLAM	ALPRAZOLAM	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	No	No
003	ALPRAZOLAM	ALPRAZOLAM	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	No	Yes
004	ALPRAZOLAM	ALPRAZOLAM	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
A078088-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09
A078088-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09
A078088-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09
A078088-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078088-001	AB
A078088-002	AB
A078088-003	AB
A078088-004	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 · 168 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	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A078088-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078088-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078088-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078088-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078088-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078088-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078088-004	AB	1	`d8e5a09893c0…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	Par Health USA, LLC	ff1630b4-2044-433c-96bc-0bb4ae8d42a0	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078088 application number: ANDA078088 ndc (product): 49884-213 ndc (product): 49884-214 ndc (product): 49884-111 ndc (product): 49884-110
Alprazolam ODT C-IV	ALPRAZOLAM ODT C-IV	Direct_Rx	3cf95203-c8b4-9f06-e063-6394a90abc9c	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078088 application number: ANDA078088

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-110	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-110	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-110	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-110	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-111	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-111	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-111	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-111	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-213	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-213	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-213	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-213	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-214	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-214	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-214	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current
49884-214	Alprazolam	alprazolam	Par Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9115	ORIG	2009-01-12
31328	ORIG	2007-09-25