Application 078631

Type: ANDA
Sponsor: PLIVA LACHEMA

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
004	CARBOPLATIN	CARBOPLATIN	INJECTABLE;INTRAVENOUS	600MG/60ML (10MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A078631-001	CARBOPLATIN	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02
A078631-002	CARBOPLATIN	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02
A078631-003	CARBOPLATIN	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02
A078631-004	CARBOPLATIN	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078631-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078631-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078631-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078631-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078631-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078631-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078631-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078631-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078631-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078631-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078631-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078631-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078631-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078631-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078631-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078631-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078631-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078631-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078631-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078631-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078631-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078631-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078631-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078631-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078631-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078631-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078631-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078631-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078631-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078631-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078631-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078631-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078631-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078631-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078631-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078631-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078631-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078631-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078631-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078631-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2008-12-02	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078631-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078631-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078631-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078631-004	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078631-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078631-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078631-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078631-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078631-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078631-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078631-003	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078631-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078631-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078631-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078631-003	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078631-004	AP	1	`ea99ee380514…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBOPLATIN	CARBOPLATIN	BPI Labs LLC	5484d2f0-0cc2-4bba-8f26-c7f6539a9606	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBOPLATIN generic name: CARBOPLATIN
KYXATA	CARBOPLATIN	Avyxa Pharma, LLC	f91c48da-68d1-4aa7-89b8-d84a3e8b629b	2025-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBOPLATIN
Carboplatin	CARBOPLATIN	Accord Healthcare, Inc.	48aa7ef3-9f44-2a08-e054-00144ff88e88	2025-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carboplatin generic name: CARBOPLATIN
CARBOPLATIN	CARBOPLATIN	Eugia US LLC	5abfcb87-bb02-4384-9c9d-7d0e3e809311	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBOPLATIN generic name: CARBOPLATIN
CARBOPLATIN	CARBOPLATIN	Eugia US LLC	f5fe9a20-47a5-45b9-ab06-c6158d9b6aca	2025-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBOPLATIN generic name: CARBOPLATIN
CARBOPLATIN	CARBOPLATIN	Teyro Labs Private Limited	f64a0cbe-7fe3-407e-8933-21c30e1a1ebc	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBOPLATIN generic name: CARBOPLATIN
Carboplatin	CARBOPLATIN	Hospira, Inc.	47677091-fd20-49af-933c-c9dd2be21de9	2024-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carboplatin generic name: CARBOPLATIN
Carboplatin	CARBOPLATIN	Hospira, Inc.	c3ae9880-44bb-4f4e-93d8-8a5e21708a30	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carboplatin generic name: CARBOPLATIN
CARBOPLATIN	CARBOPLATIN	Apotex Corp.	1c275825-0275-4c73-b650-e4c1519f13b8	2024-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBOPLATIN generic name: CARBOPLATIN
CARBOPLATIN	CARBOPLATIN	Gland Pharma Limited	9eb057eb-29ce-40d2-9ac8-ed107f25f5ab	2023-11-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBOPLATIN generic name: CARBOPLATIN
Carboplatin	CARBOPLATIN	Teva Parenteral Medicines, Inc.	e176b6ef-2ff6-498b-a9d8-7a634d147f37	2022-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carboplatin generic name: CARBOPLATIN
Carboplatin	CARBOPLATIN	Fresenius Kabi USA, LLC	b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6	2021-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carboplatin generic name: CARBOPLATIN
CARBOplatin	CARBOPLATIN	Teva Parenteral Medicines, Inc.	f330f5a2-2cad-402f-bcbb-26245a753276	2016-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBOplatin generic name: CARBOPLATIN