Application 071858

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	15MG	No	Yes
002	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	3.75MG	No	No
003	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	7.5MG	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
A071858-001	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17
A071858-002	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17
A071858-003	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071858-001	AB
A071858-002	AB
A071858-003	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	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`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	A071858-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071858-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071858-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071858-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071858-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071858-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071858-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071858-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071858-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071858-001	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
CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma LLC	919cbd07-f587-4005-acff-26213dd1d1fb	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071858 application number: ANDA071858 ndc (product): 13107-321 ndc (product): 13107-320 ndc (product): 13107-319
CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma LLC	69451c35-dd9a-4690-8d5e-4dcfa8837620	2024-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071858 application number: ANDA071858

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0030	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0030	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0030	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0030	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0040	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0040	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0040	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0040	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0070	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0070	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0070	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0070	Clorazepate Dipotassium	clorazepate dipotassium	Mylan Pharmaceuticals Inc.	ANDA	Current
13107-319	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma, LLC	ANDA	Current
13107-319	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma, LLC	ANDA	Current
13107-320	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma, LLC	ANDA	Current
13107-320	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma, LLC	ANDA	Current
13107-321	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma, LLC	ANDA	Current
13107-321	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma, LLC	ANDA	Current
43063-030	Clorazepate Dipotassium	clorazepate dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-030	Clorazepate Dipotassium	clorazepate dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-030	Clorazepate Dipotassium	clorazepate dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-030	Clorazepate Dipotassium	clorazepate dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-030	Clorazepate Dipotassium	clorazepate dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-030	Clorazepate Dipotassium	clorazepate dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-164	Clorazepate Dipotassium	clorazepate dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-350	Clorazepate Dipotassium	clorazepate dipotassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
67046-906	Clorazepate Dipotassium	Clorazepate Dipotassium	Contract Pharmacy Services-PA	ANDA	Current