Application 071756

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXAZEPAM	OXAZEPAM	CAPSULE;ORAL	15MG	No	No
002	OXAZEPAM	OXAZEPAM	CAPSULE;ORAL	10MG	No	No
003	OXAZEPAM	OXAZEPAM	CAPSULE;ORAL	30MG	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	Approval date
A071756-001	OXAZEPAM	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19
A071756-002	OXAZEPAM	OXAZEPAM	10MG	CAPSULE / ORAL	AB	1988-04-19
A071756-003	OXAZEPAM	OXAZEPAM	30MG	CAPSULE / ORAL	AB	1988-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071756-001	AB
A071756-002	AB
A071756-003	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 2 · 49 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	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071756-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB	1988-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071756-003	OXAZEPAM	30MG	CAPSULE / ORAL	AB	1988-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071756-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB	1988-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071756-003	OXAZEPAM	30MG	CAPSULE / ORAL	AB	1988-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071756-002	OXAZEPAM	10MG	CAPSULE / ORAL	AB	1988-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071756-003	OXAZEPAM	30MG	CAPSULE / ORAL	AB	1988-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071756-001	OXAZEPAM	15MG	CAPSULE / ORAL	AB	1988-04-19	`3f0d92c62455…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 49 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	A071756-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071756-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071756-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071756-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071756-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071756-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071756-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071756-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071756-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071756-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071756-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071756-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071756-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071756-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071756-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071756-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071756-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071756-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071756-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071756-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071756-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071756-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071756-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071756-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071756-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071756-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071756-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071756-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071756-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071756-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071756-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071756-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071756-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071756-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071756-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071756-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071756-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071756-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071756-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071756-001	AB	1	`3f0d92c62455…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXAZEPAM	OXAZEPAM	Leading Pharma, LLC	67f821fa-5663-4d69-82c9-5ee13a09f324	2025-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXAZEPAM generic name: OXAZEPAM
Oxazepam	OXAZEPAM	American Health Packaging	03440821-831c-4085-98f9-faa88e98c503	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxazepam generic name: OXAZEPAM
Oxazepam	OXAZEPAM	Actavis Pharma, Inc.	a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxazepam generic name: OXAZEPAM
Oxazepam	OXAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	f1e50d01-f529-4894-97d4-0af680a8b461	2022-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxazepam generic name: OXAZEPAM
Oxazepam	OXAZEPAM	TruPharma, LLC	bda8bc70-3328-46f2-89d5-7ef7a061b418	2021-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxazepam generic name: OXAZEPAM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-2810	Oxazepam	Oxazepam	Sandoz Inc	ANDA	Current
67544-294	Oxazepam	Oxazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current