Application 217219

Type: ANDA
Sponsor: PH HEALTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIOPRONIN	TIOPRONIN	TABLET, DELAYED RELEASE;ORAL	100MG	No	No
002	TIOPRONIN	TIOPRONIN	TABLET, DELAYED RELEASE;ORAL	300MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217219-001	TIOPRONIN	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-02-24
A217219-002	TIOPRONIN	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-02-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217219-001	AB
A217219-002	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 2 of 2 · 52 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
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`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	A217219-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A217219-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217219-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217219-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217219-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217219-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217219-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217219-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217219-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217219-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217219-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217219-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217219-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217219-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217219-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217219-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217219-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217219-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217219-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217219-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217219-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217219-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217219-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217219-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217219-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217219-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217219-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217219-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217219-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217219-002	AB	1	`301d65b070ca…`
2023-05-13 08:27 UTC	2023-05	A217219-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A217219-002	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217219-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217219-002	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TIOPRONIN	TIOPRONIN	Par Health USA, LLC	5396b9fd-5385-44fd-a8ba-e56a46a33bc7	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217219 application number: ANDA217219

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73991	ORIG	2023-04-14