Application 080285

Type: ANDA
Sponsor: ANABOLIC

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 43.

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
A080285-001	PROPYLTHIOURACIL	PROPYLTHIOURACIL	50MG	TABLET / ORAL		Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A080285-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080285-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080285-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	Approved before 1982	`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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propylthiouracil	PROPYLTHIOURACIL	American Health Packaging	d819e532-09ac-434a-84a6-636c4204c7aa	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propylthiouracil generic name: PROPYLTHIOURACIL
Propylthiouracil	PROPYLTHIOURACIL	Par Health USA, LLC	b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propylthiouracil generic name: PROPYLTHIOURACIL
PROPYLTHIOURACIL	PROPYLTHIOURACIL	Bryant Ranch Prepack	a032648a-a6e4-4356-a483-8eee03779030	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROPYLTHIOURACIL generic name: PROPYLTHIOURACIL
Propylthiouracil	PROPYLTHIOURACIL	Macleods Pharmaceuticals Limited	a251e4cb-01f1-4fd8-bd30-362126b85073	2024-09-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propylthiouracil generic name: PROPYLTHIOURACIL
PROPYLTHIOURACIL	PROPYLTHIOURACIL	Bryant Ranch Prepack	ae65e8b0-91b2-4a3f-8e1a-279e47eee951	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROPYLTHIOURACIL generic name: PROPYLTHIOURACIL
Propylthiouracil	PROPYLTHIOURACIL	Chartwell RX, LLC	53c5f586-3e72-479d-89ba-379683c8f6ba	2023-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propylthiouracil generic name: PROPYLTHIOURACIL
Propylthiouracil	PROPYLTHIOURACIL	Teva Pharmaceuticals, Inc.	804fa92a-a5ba-4be0-aa44-a40a2e89fde6	2023-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propylthiouracil generic name: PROPYLTHIOURACIL
PROPYLTHIOURACIL	PROPYLTHIOURACIL	QUAGEN PHARMACEUTICALS LLC	84eae11a-b572-4570-b288-ac2cdd374186	2023-02-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROPYLTHIOURACIL generic name: PROPYLTHIOURACIL

Reported adverse events (FAERS/openFDA)#

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