Application 070928

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIAZEPAM	DIAZEPAM	SOLUTION;ORAL	5MG/5ML	No	Yes

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
A070928-001	DIAZEPAM	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070928-001	AA

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`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	A070928-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070928-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070928-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070928-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070928-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070928-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070928-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070928-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070928-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070928-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070928-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070928-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070928-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070928-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070928-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070928-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070928-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070928-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070928-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070928-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070928-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070928-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070928-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070928-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070928-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070928-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070928-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070928-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070928-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070928-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070928-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070928-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070928-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070928-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070928-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070928-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070928-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070928-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070928-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070928-001	AA	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	Precision Dose Inc.	78d5a77d-5ca7-4f16-b4d0-fce86456593c	2025-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928 ndc (product): 68094-750
Diazepam	DIAZEPAM	Hikma Pharmaceuticals USA Inc.	9e85abed-1a8b-4762-a31f-f2c7f196b8af	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928 ndc (product): 0054-3188
Diazepam	DIAZEPAM	American Health Packaging	aeadf0b0-918b-40e0-a5e8-60b2fcbd5ded	2023-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928
Diazepam	DIAZEPAM	Pharmaceutical Associates, Inc.	b24f1eb7-3dab-4183-b81f-f86ac62aedd8	2021-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928 ndc (product): 0121-0905

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-3188	Diazepam	Diazepam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3188	Diazepam	Diazepam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3188	Diazepam	Diazepam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3188	Diazepam	Diazepam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3188	Diazepam	Diazepam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0121-0905	Diazepam	Diazepam	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0905	Diazepam	Diazepam	Pharmaceutical Associates, Inc.	ANDA	Current
0904-7117	Diazepam	Diazepam	Major Pharmaceuticals	ANDA	Current
17856-3188	Diazepam	Diazepam	Atlantic Biologicals Corps	ANDA	Current
17856-3188	Diazepam	Diazepam	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-3188	Diazepam	Diazepam	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-3188	Diazepam	Diazepam	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
68094-750	Diazepam	Diazepam	Precision Dose Inc.	ANDA	Current
68094-750	Diazepam	Diazepam	Precision Dose Inc.	ANDA	Current
68094-750	Diazepam	Diazepam	Precision Dose Inc.	ANDA	Current
68094-750	Diazepam	Diazepam	Precision Dose Inc.	ANDA	Current
68094-750	Diazepam	Diazepam	Precision Dose Inc.	ANDA	Current