Application 072253

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXAZEPAM	OXAZEPAM	CAPSULE;ORAL	30MG	No	Yes
002	OXAZEPAM	OXAZEPAM	CAPSULE;ORAL	10MG	No	No
003	OXAZEPAM	OXAZEPAM	CAPSULE;ORAL	15MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072253-001	OXAZEPAM	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14
A072253-002	OXAZEPAM	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14
A072253-003	OXAZEPAM	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A072253-001	AB
A072253-002	AB
A072253-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072253-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB		1988-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072253-003	OXAZEPAM	15MG	CAPSULE / ORAL	AB		1988-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072253-001	OXAZEPAM	30MG	CAPSULE / ORAL	AB	RS	1988-04-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A072253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072253-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072253-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072253-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072253-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072253-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072253-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072253-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072253-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072253-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072253-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072253-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072253-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072253-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072253-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072253-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072253-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072253-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072253-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072253-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072253-001	AB	1	`8072bd15b7f6…`

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
Oxazepam	OXAZEPAM	American Health Packaging	03440821-831c-4085-98f9-faa88e98c503	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072253 application number: ANDA072253 ndc (product): 62584-812 ndc (product): 62584-813 ndc (product): 62584-814
Oxazepam	OXAZEPAM	Actavis Pharma, Inc.	a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072253 application number: ANDA072253 ndc (product): 0228-2069 ndc (product): 0228-2073 ndc (product): 0228-2067

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2067	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2067	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2067	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2067	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2067	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2067	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2069	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2069	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2069	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2069	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2069	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2069	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2073	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2073	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2073	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2073	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2073	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2073	Oxazepam	Oxazepam	Actavis Pharma, Inc.	ANDA	Current
43353-074	Oxazepam	Oxazepam	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
62584-812	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-812	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-812	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-812	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-813	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-813	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-813	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-813	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-814	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-814	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-814	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current
62584-814	Oxazepam	Oxazepam	American Health Packaging	ANDA	Current