Application 076517

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBOPLATIN	CARBOPLATIN	INJECTABLE;INTRAVENOUS	50MG/5ML (10MG/ML)	No	No
002	CARBOPLATIN	CARBOPLATIN	INJECTABLE;INTRAVENOUS	150MG/15ML (10MG/ML)	No	No
003	CARBOPLATIN	CARBOPLATIN	INJECTABLE;INTRAVENOUS	450MG/45ML (10MG/ML)	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076517-001	CARBOPLATIN	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14
A076517-002	CARBOPLATIN	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14
A076517-003	CARBOPLATIN	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076517-001	AP
A076517-002	AP
A076517-003	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 4 · 126 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	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076517-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076517-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076517-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2004-10-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A076517-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076517-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076517-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076517-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076517-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076517-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076517-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076517-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076517-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076517-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076517-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076517-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076517-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076517-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076517-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076517-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076517-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076517-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076517-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076517-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076517-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076517-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076517-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076517-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076517-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076517-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076517-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076517-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076517-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076517-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076517-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076517-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076517-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076517-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076517-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076517-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076517-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076517-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076517-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076517-001	AP	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carboplatin	CARBOPLATIN	Hospira, Inc.	47677091-fd20-49af-933c-c9dd2be21de9	2024-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076517 application number: ANDA076517 ndc (product): 61703-150 ndc (product): 61703-360 ndc (product): 61703-262
Carboplatin	CARBOPLATIN	Hospira, Inc.	c3ae9880-44bb-4f4e-93d8-8a5e21708a30	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076517 application number: ANDA076517 ndc (product): 61703-339

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61703-150	Carboplatin	Carboplatin	Hospira, Inc.	ANDA	Current
61703-262	Carboplatin	Carboplatin	Hospira, Inc.	ANDA	Current
61703-339	Carboplatin	Carboplatin	Hospira, Inc.	ANDA	Current
61703-339	Carboplatin	Carboplatin	Hospira, Inc.	ANDA	Current
61703-339	Carboplatin	Carboplatin	Hospira, Inc.	ANDA	Current
61703-339	Carboplatin	Carboplatin	Hospira, Inc.	ANDA	Current
61703-339	Carboplatin	Carboplatin	Hospira, Inc.	ANDA	Current
61703-339	Carboplatin	Carboplatin	Hospira, Inc.	ANDA	Current
61703-360	Carboplatin	Carboplatin	Hospira, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8921	ORIG	2004-10-18