Application 020648

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIASTAT	DIAZEPAM	GEL;RECTAL	2.5MG/0.5ML (5MG/ML)	Yes	No
002	DIASTAT	DIAZEPAM	GEL;RECTAL	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	DIASTAT	DIAZEPAM	GEL;RECTAL	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	DIASTAT	DIAZEPAM	GEL;RECTAL	15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	DIASTAT	DIAZEPAM	GEL;RECTAL	20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
006	DIASTAT ACUDIAL	DIAZEPAM	GEL;RECTAL	20MG/4ML (5MG/ML)	Yes	Yes
007	DIASTAT ACUDIAL	DIAZEPAM	GEL;RECTAL	10MG/2ML (5MG/ML)	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020648-001	DIASTAT	DIAZEPAM	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	1997-07-29
N020648-002	DIASTAT	DIAZEPAM	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29
N020648-003	DIASTAT	DIAZEPAM	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29
N020648-004	DIASTAT	DIAZEPAM	15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29
N020648-005	DIASTAT	DIAZEPAM	20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29
N020648-006	DIASTAT ACUDIAL	DIAZEPAM	20MG/4ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15
N020648-007	DIASTAT ACUDIAL	DIAZEPAM	10MG/2ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020648-001	AB
N020648-006	AB
N020648-007	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 8 · 287 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	N020648-001	DIASTAT	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	1997-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020648-002	DIASTAT	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020648-003	DIASTAT	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020648-004	DIASTAT	15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020648-005	DIASTAT	20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020648-006	DIASTAT ACUDIAL	20MG/4ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020648-007	DIASTAT ACUDIAL	10MG/2ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020648-001	DIASTAT	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	1997-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020648-002	DIASTAT	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020648-003	DIASTAT	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020648-004	DIASTAT	15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020648-005	DIASTAT	20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020648-006	DIASTAT ACUDIAL	20MG/4ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020648-007	DIASTAT ACUDIAL	10MG/2ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020648-001	DIASTAT	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL		RLD, RS	1997-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020648-002	DIASTAT	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020648-003	DIASTAT	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020648-004	DIASTAT	15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020648-005	DIASTAT	20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020648-006	DIASTAT ACUDIAL	20MG/4ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020648-007	DIASTAT ACUDIAL	10MG/2ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020648-001	DIASTAT	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL		RLD, RS	1997-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020648-002	DIASTAT	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020648-003	DIASTAT	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020648-004	DIASTAT	15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020648-005	DIASTAT	20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020648-006	DIASTAT ACUDIAL	20MG/4ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020648-007	DIASTAT ACUDIAL	10MG/2ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020648-001	DIASTAT	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL		RLD, RS	1997-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020648-002	DIASTAT	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020648-003	DIASTAT	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020648-004	DIASTAT	15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020648-005	DIASTAT	20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020648-006	DIASTAT ACUDIAL	20MG/4ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020648-007	DIASTAT ACUDIAL	10MG/2ML (5MG/ML)	GEL / RECTAL	AB	RLD, RS	2005-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020648-001	DIASTAT	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL		RLD, RS	1997-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020648-002	DIASTAT	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020648-003	DIASTAT	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020648-004	DIASTAT	15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020648-005	DIASTAT	20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / RECTAL		RLD	1997-07-29	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 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	N020648-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020648-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020648-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020648-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020648-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020648-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020648-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020648-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020648-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020648-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020648-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020648-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020648-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020648-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020648-006	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020648-007	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020648-006	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020648-007	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020648-006	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020648-007	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020648-006	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020648-007	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020648-006	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020648-007	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020648-006	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020648-007	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020648-006	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020648-007	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020648-006	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020648-007	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020648-006	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020648-007	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020648-006	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020648-007	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020648-006	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020648-007	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020648-006	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020648-007	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020648-006	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020648-007	AB	1	`9b2671bbb829…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	Oceanside Pharmaceuticals	b1b2848b-b265-4f6f-9141-bf106dec0726	2024-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020648 application number: NDA020648 ndc (product): 68682-652 ndc (product): 68682-655 ndc (product): 68682-650

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-6137	Diazepam	Diazepam	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-6138	Diazepam	Diazepam	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-6138	Diazepam	Diazepam	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-6139	Diazepam	Diazepam	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-6139	Diazepam	Diazepam	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0187-0658	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0658	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0658	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0658	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0658	Diastat	diazepam	Bausch Health US LLC	NDA	Current
0187-0658	Diastat	diazepam	Bausch Health Americas, Inc.	NDA	Current
0187-0658	Diastat	diazepam	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0658	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0658	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0659	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0659	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0659	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0659	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0659	Diastat	diazepam	Bausch Health US LLC	NDA	Current
0187-0659	Diastat	diazepam	Bausch Health Americas, Inc.	NDA	Current
0187-0659	Diastat	diazepam	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0659	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
0187-0659	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
66490-650	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
66490-650	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
66490-650	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
66490-650	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
66490-650	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
66490-650	Diastat	diazepam	Valeant Pharmaceuticals North America LLC	NDA	Current
66490-650	Diastat	diazepam	Bausch Health US, LLC	NDA	Current
68682-650	Diazepam	Diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-650	Diazepam	Diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-650	Diazepam	Diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-650	Diazepam	Diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-652	Diazepam	diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-652	Diazepam	diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-652	Diazepam	diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-652	Diazepam	diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-655	Diazepam	Diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-655	Diazepam	Diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-655	Diazepam	Diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-655	Diazepam	Diazepam	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80487	SUPPL	2024-12-04
80448	SUPPL	2024-11-29
80447	SUPPL	2024-11-29
73198	SUPPL	2023-01-17
73176	SUPPL	2023-01-17
66890	SUPPL	2021-03-26
66888	SUPPL	2021-03-26
66201	SUPPL	2021-02-12
66123	SUPPL	2021-02-09
46469	SUPPL	2016-12-22
46378	SUPPL	2016-12-21
46241	SUPPL	2016-12-20
45732	SUPPL	2016-10-31
35076	SUPPL	2014-12-17
25442	SUPPL	2014-12-17
25441	SUPPL	2013-09-03
20805	SUPPL	2007-07-06
23588	ORIG	2006-03-31
35075	SUPPL	2006-03-27
23060	SUPPL	2006-03-27
25440	SUPPL	2005-09-22
25439	SUPPL	2001-04-11