Application 080154

Type: ANDA
Sponsor: QUAGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPYLTHIOURACIL	PROPYLTHIOURACIL	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A080154-001	PROPYLTHIOURACIL	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080154-001	BD

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A080154-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080154-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080154-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080154-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A080154-001	BD	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A080154-001	BD	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080154-001	BD	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080154-001	BD	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080154-001	BD	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080154-001	BD	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080154-001	BD	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080154-001	BD	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080154-001	BD	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080154-001	BD	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080154-001	BD	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080154-001	BD	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080154-001	BD	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080154-001	BD	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080154-001	BD	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080154-001	BD	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080154-001	BD	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080154-001	BD	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080154-001	BD	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080154-001	BD	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A080154-001	BD	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080154-001	BD	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080154-001	BD	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080154-001	BD	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080154-001	BD	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080154-001	BD	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080154-001	BD	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080154-001	BD	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080154-001	BD	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080154-001	BD	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080154-001	BD	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080154-001	BD	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080154-001	BD	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080154-001	BD	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080154-001	BD	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080154-001	BD	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080154-001	BD	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROPYLTHIOURACIL	PROPYLTHIOURACIL	Bryant Ranch Prepack	a032648a-a6e4-4356-a483-8eee03779030	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080154 application number: ANDA080154
PROPYLTHIOURACIL	PROPYLTHIOURACIL	Bryant Ranch Prepack	ae65e8b0-91b2-4a3f-8e1a-279e47eee951	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080154 application number: ANDA080154
PROPYLTHIOURACIL	PROPYLTHIOURACIL	QUAGEN PHARMACEUTICALS LLC	84eae11a-b572-4570-b288-ac2cdd374186	2023-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080154 application number: ANDA080154 ndc (product): 70752-171

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1480	Propylthiouracil	Propylthiouracil	West-Ward Pharmaceutical Corp	ANDA	Current
42254-010	Propylthiouracil	Propylthiouracil	Rebel Distributors Corp.	ANDA	Current
70752-171	PROPYLTHIOURACIL	PROPYLTHIOURACIL	QUAGEN PHARMACEUTICALS LLC	ANDA	Current