Application 208264

Type: NDA
Sponsor: ADIENNE SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEPADINA	THIOTEPA	POWDER;INTRAVENOUS	15MG/VIAL	Yes	Yes
002	TEPADINA	THIOTEPA	POWDER;INTRAVENOUS	100MG/VIAL	Yes	Yes
003	TEPADINA AND SODIUM CHLORIDE	THIOTEPA	POWDER;INTRAVENOUS	200MG	Yes	Yes
004	TEPADINA AND SODIUM CHLORIDE	THIOTEPA	POWDER;INTRAVENOUS	400MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208264-001	TEPADINA	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26
N208264-002	TEPADINA	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26
N208264-003	TEPADINA AND SODIUM CHLORIDE	THIOTEPA	200MG	POWDER / INTRAVENOUS		RLD, RS	2025-04-10
N208264-004	TEPADINA AND SODIUM CHLORIDE	THIOTEPA	400MG	POWDER / INTRAVENOUS		RLD, RS	2026-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208264-001	AP
N208264-002	AP

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208264-003	9931458	2037-05-31		Drug product	2025-05-09
N208264-004	9931458	2037-05-31		Drug product	2026-02-12

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 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208264-003	TEPADINA AND SODIUM CHLORIDE	200MG	POWDER / INTRAVENOUS		RLD, RS	2025-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208264-004	TEPADINA AND SODIUM CHLORIDE	400MG	POWDER / INTRAVENOUS		RLD, RS	2026-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208264-003	TEPADINA AND SODIUM CHLORIDE	200MG	POWDER / INTRAVENOUS		RLD, RS	2025-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208264-004	TEPADINA AND SODIUM CHLORIDE	400MG	POWDER / INTRAVENOUS		RLD, RS	2026-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-003	TEPADINA AND SODIUM CHLORIDE	200MG	POWDER / INTRAVENOUS		RLD, RS	2025-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208264-003	TEPADINA AND SODIUM CHLORIDE	200MG	POWDER / INTRAVENOUS		RLD, RS	2025-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N208264-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208264-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208264-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208264-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208264-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208264-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208264-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208264-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208264-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208264-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208264-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208264-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208264-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208264-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208264-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208264-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208264-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208264-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208264-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208264-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208264-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208264-002	AP	1	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208264-003	9931458	2037-05-31	Drug product	2025-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208264-004	9931458	2037-05-31	Drug product	2026-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208264-003	9931458	2037-05-31	Drug product	2025-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-003	9931458	2037-05-31	Drug product	2025-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208264-003	9931458	2037-05-31	Drug product	2025-05-09	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208264-003	9931458	2037-05-31	Drug product	2025-05-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208264-004	9931458	2037-05-31	Drug product	2026-02-12	`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-001	ODE-129	2024-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-002	ODE-129	2024-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-001	ODE-129	2024-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-002	ODE-129	2024-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-001	ODE-129	2024-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-002	ODE-129	2024-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-001	ODE-129	2024-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-002	ODE-129	2024-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208264-001	ODE-129	2024-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208264-002	ODE-129	2024-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-001	ODE-129	2024-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-002	ODE-129	2024-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-001	ODE-129	2024-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-002	ODE-129	2024-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-001	ODE-129	2024-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-002	ODE-129	2024-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208264-001	ODE-129	2024-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208264-002	ODE-129	2024-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-001	ODE-129	2024-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-002	ODE-129	2024-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208264-001	ODE-129	2024-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208264-002	ODE-129	2024-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208264-001	ODE-129	2024-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208264-002	ODE-129	2024-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208264-001	I-747	2020-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208264-001	ODE-129	2024-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208264-002	I-747	2020-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208264-002	ODE-129	2024-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208264-001	ODE-129	2024-01-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208264-002	ODE-129	2024-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208264-001	ODE-129	2024-01-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208264-002	ODE-129	2024-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208264-001	ODE-129	2024-01-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208264-002	ODE-129	2024-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208264-001	ODE-129	2024-01-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208264-002	ODE-129	2024-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208264-001	I-747	2020-01-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208264-001	ODE-129	2024-01-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208264-002	I-747	2020-01-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208264-002	ODE-129	2024-01-26	`8869cabd3fbd…`

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
TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	559e353c-2dc0-16ba-e054-00144ff8d46c	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208264 application number: NDA208264 ndc (product): 70121-1630 ndc (product): 70121-1631

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53964-001	TEPADINA	THIOTEPA	ADIENNE SA	NDA	Current
53964-002	TEPADINA	THIOTEPA	ADIENNE SA	NDA	Current
70121-1630	TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	NDA	Current
70121-1630	TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	NDA	Current
70121-1630	TEPADINA	THIOTEPA	Amneal Biosciences LLC	NDA	Current
70121-1630	TEPADINA	THIOTEPA	Amneal Biosciences LLC	NDA	Current
70121-1630	TEPADINA	THIOTEPA	Amneal Biosciences LLC	NDA	Current
70121-1630	TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	NDA	Current
70121-1630	TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	NDA	Current
70121-1631	TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	NDA	Current
70121-1631	TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	NDA	Current
70121-1631	TEPADINA	THIOTEPA	Amneal Biosciences LLC	NDA	Current
70121-1631	TEPADINA	THIOTEPA	Amneal Biosciences LLC	NDA	Current
70121-1631	TEPADINA	THIOTEPA	Amneal Biosciences LLC	NDA	Current
70121-1631	TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	NDA	Current
70121-1631	TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85468	SUPPL	2026-03-23
85467	SUPPL	2026-03-23
85466	SUPPL	2026-03-23
85465	SUPPL	2026-03-23
85464	SUPPL	2026-03-23
85462	SUPPL	2026-03-23
74327	SUPPL	2023-05-23
74322	SUPPL	2023-05-19
61481	SUPPL	2019-12-31
54776	ORIG	2018-07-06
47010	ORIG	2017-01-30
46992	ORIG	2017-01-26