Application 076657

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IFOSFAMIDE	IFOSFAMIDE	INJECTABLE;INJECTION	1GM/20ML (50MG/ML)	No	Yes
002	IFOSFAMIDE	IFOSFAMIDE	INJECTABLE;INJECTION	3GM/60ML (50MG/ML)	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076657-001	IFOSFAMIDE	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04
A076657-002	IFOSFAMIDE	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076657-001	AP
A076657-002	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.

Product history page 1 of 3 · 86 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
2026-09-14 22:38:34	2026-08	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076657-001	IFOSFAMIDE	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076657-002	IFOSFAMIDE	3GM/60ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076657-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076657-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076657-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076657-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076657-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076657-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076657-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076657-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076657-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076657-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076657-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076657-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076657-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076657-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076657-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076657-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076657-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076657-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076657-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076657-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076657-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076657-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076657-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076657-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076657-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076657-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076657-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076657-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076657-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076657-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076657-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076657-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076657-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076657-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076657-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076657-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076657-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076657-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076657-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076657-002	AP	1	`74a2ff9319b5…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ifosfamide	IFOSFAMIDE FOR INJECTION	SteriMax Inc.	98798c5e-8384-4990-a1b5-60dfb1e667bb	2026-09-01		Name fallback brand name: Ifosfamide
Ifosfamide	IFOSFAMIDE	Fresenius Kabi USA, LLC	a311a947-7b78-4226-bfe0-f4aa0be20e27	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ifosfamide generic name: IFOSFAMIDE
IFEX	IFOSFAMIDE	Baxter Healthcare Corporation	b7241707-7538-4d1a-91e7-3a25a91e0b9a	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IFOSFAMIDE
IFOSFAMIDE	IFOSFAMIDE	Baxter Healthcare Company	91e433a9-6800-43a6-ac13-a49a04a5aecd	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IFOSFAMIDE generic name: IFOSFAMIDE
IFOSFAMIDE	IFOSFAMIDE	Baxter Healthcare Company	efb1d03b-2d91-406e-8110-d3a58b8fa7cc	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IFOSFAMIDE generic name: IFOSFAMIDE
Ifosfamide	IFOSFAMIDE	Hikma Pharmaceuticals USA Inc.	c90ab05f-8fe5-437e-a1c0-8b11ef63291e	2020-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ifosfamide generic name: IFOSFAMIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-3427	Ifosfamide	Ifosfamide	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3427	Ifosfamide	Ifosfamide	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3427	Ifosfamide	Ifosfamide	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3429	Ifosfamide	Ifosfamide	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3429	Ifosfamide	Ifosfamide	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3429	Ifosfamide	Ifosfamide	Teva Parenteral Medicines, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39514	SUPPL	2015-07-17
39513	SUPPL	2015-07-17
18449	SUPPL	2015-07-17