Application 071307

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIAZEPAM	DIAZEPAM	TABLET;ORAL	2MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071307-001	DIAZEPAM	DIAZEPAM	2MG	TABLET / ORAL	AB		1986-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071307-001	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 · 41 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	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A071307-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071307-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071307-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071307-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071307-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071307-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071307-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071307-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071307-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071307-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071307-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071307-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071307-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071307-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071307-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071307-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071307-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071307-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071307-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071307-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071307-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071307-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071307-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071307-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071307-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071307-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071307-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071307-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071307-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071307-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071307-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071307-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071307-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071307-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071307-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071307-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071307-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071307-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071307-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071307-001	AB	1	`cb3db0bc1861…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	1ad84940-40f7-457a-8ffa-53e1a7bfee16	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307 ndc (product): 43063-840
Diazepam	DIAZEPAM	A-S Medication Solutions	ec433be5-d84d-425f-9edf-71263f885eec	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307 ndc (product): 50090-0195
Diazepam	DIAZEPAM	Asclemed USA, Inc.	32e7bfa1-6060-4041-a0e5-249cacb84ebc	2025-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307
Diazepam	DIAZEPAM	Bryant Ranch Prepack	04cc10ad-7d5c-434e-9b29-85b14071492b	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307 ndc (product): 63629-2948
Diazepam	DIAZEPAM	Teva Pharmaceuticals USA, Inc.	48aa32cb-047a-414a-822e-82a5f26d8817	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307 ndc (product): 0172-3925
Diazepam	DIAZEPAM	Clinical Solutions Wholesale, LLC	83c1f93b-0fc6-4512-9c8f-9167b217d7f9	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307 ndc (product): 58118-3925
Diazepam	DIAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	b29916fb-1781-4112-9c3e-45478754d638	2017-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307 ndc (product): 43353-825

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0172-3925	Diazepam	Diazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-3925	Diazepam	Diazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-3925	Diazepam	Diazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-3925	Diazepam	Diazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
21695-263	Diazepam	Diazepam	Rebel Distributors Corp.	ANDA	Current
43063-840	Diazepam	Diazepam	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-840	Diazepam	Diazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-840	Diazepam	Diazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-840	Diazepam	Diazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-840	Diazepam	Diazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-825	Diazepam	Diazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0195	Diazepam	Diazepam	A-S Medication Solutions	ANDA	Current
50090-0195	Diazepam	Diazepam	A-S Medication Solutions	ANDA	Current
55700-058	Diazepam	Diazepam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-058	Diazepam	Diazepam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-058	Diazepam	Diazepam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-058	Diazepam	Diazepam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-058	Diazepam	Diazepam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-058	Diazepam	Diazepam	Quality Care Products, LLC	ANDA	Current
58118-3925	Diazepam	Diazepam	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-3925	Diazepam	Diazepam	Clinical Solutions Wholesale, LLC	ANDA	Current
63629-2948	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
63629-2948	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
63629-2948	Diazepam	Diazepam	Bryant Ranch Prepack	ANDA	Current
64725-3925	Diazepam	Diazepam	TYA Pharmaceuticals	ANDA	Current
67046-945	Diazepam	Diazepam	Contract Pharmacy Services-PA	ANDA	Current
67296-0291	Diazepam	Diazepam	Redpharm Drug, Inc.	ANDA	Current
67296-0291	Diazepam	Diazepam	Redpharm Drug, Inc.	ANDA	Current
67296-0291	Diazepam	Diazepam	Redpharm Drug, Inc.	ANDA	Current
70518-1856	Diazepam	Diazepam	REMEDYREPACK INC.	ANDA	Current
70518-1856	Diazepam	Diazepam	REMEDYREPACK INC.	ANDA	Current
70518-1856	Diazepam	Diazepam	REMEDYREPACK INC.	ANDA	Current
70518-1856	Diazepam	Diazepam	REMEDYREPACK INC.	ANDA	Current
72189-193	DIAZEPAM	DIAZEPAM	DirectRX	ANDA	Current