Application 216198

Type: ANDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIOPRONIN	TIOPRONIN	TABLET;ORAL	100MG	No	No

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

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
A216198-001	TIOPRONIN	TIOPRONIN	100MG	TABLET / ORAL			2022-06-02

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.

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	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216198-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2022-06-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216198-001	TIOPRONIN	100MG	TABLET / ORAL		2022-06-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216198-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216198-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216198-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216198-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216198-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216198-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216198-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216198-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216198-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216198-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216198-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216198-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216198-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216198-001	AB	1	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VENXXIVA	TIOPRONIN	Cycle Pharmaceuticals Ltd.	02e24443-04c6-4b98-a395-49aec4a468de	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: TIOPRONIN
Thiola EC	TIOPRONIN	Mission Pharmacal Company	20298a52-a194-a161-8632-d84b6f26e23c	2025-10-07	Warnings, Adverse reactions	Name fallback generic name: TIOPRONIN
Thiola	TIOPRONIN	Mission Pharmacal Company	494a714e-923c-cd57-df6c-12886afb265a	2025-09-25	Warnings, Adverse reactions	Name fallback generic name: TIOPRONIN
Tiopronin	TIOPRONIN	BioComp Pharma, Inc.	1f2eb1d6-faa6-e352-e063-6294a90a7fb5	2025-06-05	Warnings, Adverse reactions	Name fallback brand name: Tiopronin generic name: TIOPRONIN
Tiopronin	TIOPRONIN	Teva Pharmaceuticals USA, Inc.	8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b9	2025-04-14	Warnings, Adverse reactions	Name fallback brand name: Tiopronin generic name: TIOPRONIN
TIOPRONIN	TIOPRONIN	Torrent Pharmaceuticals Limited	ad750031-08ec-4d92-af2d-97a80c454e14	2024-11-01	Warnings, Adverse reactions	Name fallback brand name: TIOPRONIN generic name: TIOPRONIN
Tiopronin	TIOPRONIN	Teva Pharmaceuticals, Inc.	749257d9-a519-4b10-9058-7fe3f301cdd2	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Tiopronin generic name: TIOPRONIN
tiopronin	TIOPRONIN	Amneal Pharmaceuticals NY LLC	ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: tiopronin generic name: TIOPRONIN
TIOPRONIN	TIOPRONIN	Endo USA, Inc.	5396b9fd-5385-44fd-a8ba-e56a46a33bc7	2022-11-16	Warnings, Adverse reactions	Name fallback brand name: TIOPRONIN generic name: TIOPRONIN