Application 217559

Type: ANDA
Sponsor: REGCON HOLDINGS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THIOTEPA	THIOTEPA	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	15MG/VIAL	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
A217559-001	THIOTEPA	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP		2024-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217559-001	AP

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	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217559-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2024-08-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217559-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217559-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217559-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217559-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217559-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217559-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217559-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217559-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217559-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217559-001	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217559-001	AP	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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	559e353c-2dc0-16ba-e054-00144ff8d46c	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: THIOTEPA
Thiotepa	THIOTEPA	Gland Pharma Limited	6cd6ae89-c553-4328-9262-4363610a1f19	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Thiotepa generic name: THIOTEPA
Thiotepa	THIOTEPA	Sagent Pharmaceuticals	448c29f1-6d9c-4f8e-8a69-9b85e973e728	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Thiotepa generic name: THIOTEPA
TEPYLUTE	THIOTEPA	Shorla Oncology Inc.	add44e98-a042-4e38-b870-beb36693805b	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: THIOTEPA
Thiotepa	THIOTEPA	Novadoz Pharmaceuticals LLC	b702dcc9-dd0e-4386-b1e2-f20562fd2ad9	2024-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Thiotepa generic name: THIOTEPA
Thiotepa	THIOTEPA	Meitheal Pharmaceuticals Inc	4b4725eb-95f1-45cc-852f-152beb5f1e2c	2023-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Thiotepa generic name: THIOTEPA
Thiotepa	THIOTEPA	Hikma Pharmaceuticals USA Inc.	9ae8063c-ba28-4da2-a94c-8e1a5f75e4b3	2023-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Thiotepa generic name: THIOTEPA
Thiotepa	THIOTEPA	Hikma Pharmaceuticals USA Inc.	6dc898dc-5949-4aa4-83f8-4bd20c29eb93	2023-05-24	Warnings, Adverse reactions	Name fallback brand name: Thiotepa generic name: THIOTEPA
Thiotepa	THIOTEPA	Dr.Reddy's Laboratories Inc.,	a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Thiotepa generic name: THIOTEPA
Thiotepa	THIOTEPA	Fresenius Kabi USA, LLC	493410f3-0733-4f76-8050-6529d96f2a5b	2022-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Thiotepa generic name: THIOTEPA
Thiotepa	THIOTEPA	Hikma Pharmaceuticals USA Inc.	b19b03db-471d-4ee7-b1b8-6eccc39c41b0	2021-04-02	Warnings, Adverse reactions	Name fallback brand name: Thiotepa generic name: THIOTEPA
Thiotepa	THIOTEPA	Dr.Reddy's Laboratories Inc.,	0def6a5e-4bf5-b1fd-47b7-0f17ecfd9bc2	2018-04-25	Warnings, Adverse reactions	Name fallback brand name: Thiotepa generic name: THIOTEPA