Application 201781

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEMAZEPAM	TEMAZEPAM	CAPSULE;ORAL	7.5MG	No	No
002	TEMAZEPAM	TEMAZEPAM	CAPSULE;ORAL	15MG	No	No
003	TEMAZEPAM	TEMAZEPAM	CAPSULE;ORAL	22.5MG	No	No
004	TEMAZEPAM	TEMAZEPAM	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201781-001	TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04
A201781-002	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04
A201781-003	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04
A201781-004	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A201781-001	AB
A201781-002	AB
A201781-003	AB
A201781-004	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 5 · 164 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	A201781-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201781-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201781-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201781-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201781-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201781-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201781-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201781-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201781-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201781-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201781-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201781-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201781-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201781-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201781-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201781-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201781-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201781-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201781-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201781-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201781-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201781-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201781-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201781-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201781-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201781-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201781-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201781-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201781-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201781-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201781-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201781-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201781-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201781-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201781-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201781-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201781-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2015-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201781-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2015-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201781-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2015-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201781-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2015-06-04	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A201781-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201781-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201781-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201781-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201781-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201781-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201781-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201781-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201781-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201781-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201781-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201781-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201781-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201781-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201781-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201781-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201781-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201781-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201781-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201781-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201781-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201781-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201781-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201781-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201781-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201781-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201781-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201781-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201781-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201781-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201781-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201781-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201781-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201781-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201781-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201781-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201781-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201781-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201781-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201781-004	AB	1	`d06236e962d9…`

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
Temazepam	TEMAZEPAM	Solco Healthcare U.S., LLC	3ce42f0e-821e-4c9a-8f6b-60621628fd4b	2024-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201781 application number: ANDA201781 ndc (product): 43547-611 ndc (product): 43547-613 ndc (product): 43547-614 ndc (product): 43547-612

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-611	Temazepam	temazepam	Solco Healthcare U.S., LLC	ANDA	Current
43547-611	Temazepam	temazepam	Solco Healthcare U.S., LLC	ANDA	Current
43547-612	Temazepam	temazepam	Solco Healthcare U.S., LLC	ANDA	Current
43547-612	Temazepam	temazepam	Solco Healthcare U.S., LLC	ANDA	Current
43547-613	Temazepam	temazepam	Solco Healthcare U.S., LLC	ANDA	Current
43547-613	Temazepam	temazepam	Solco Healthcare U.S., LLC	ANDA	Current
43547-614	Temazepam	temazepam	Solco Healthcare U.S., LLC	ANDA	Current
43547-614	Temazepam	temazepam	Solco Healthcare U.S., LLC	ANDA	Current