Application 077861

Type: ANDA
Sponsor: CIPLA LTD

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 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	Approval date
A077861-001	CARBOPLATIN	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18
A077861-002	CARBOPLATIN	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18
A077861-003	CARBOPLATIN	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18
A077861-004	CARBOPLATIN	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A077861-001	AP
A077861-002	AP
A077861-003	AP
A077861-004	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 5 · 168 observed 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
2026-08-18 06:07:40	2026-07	A077861-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077861-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077861-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077861-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077861-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077861-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077861-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077861-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077861-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077861-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077861-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077861-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077861-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077861-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077861-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077861-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077861-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077861-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077861-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077861-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077861-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077861-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077861-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077861-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077861-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077861-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077861-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077861-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077861-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077861-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077861-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077861-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077861-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077861-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077861-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077861-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077861-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077861-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077861-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077861-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2007-01-18	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A077861-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077861-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077861-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077861-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077861-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077861-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077861-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077861-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077861-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077861-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077861-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077861-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077861-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077861-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077861-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077861-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077861-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077861-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077861-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077861-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077861-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077861-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077861-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077861-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077861-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077861-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077861-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077861-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077861-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077861-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077861-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077861-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077861-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077861-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077861-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077861-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077861-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077861-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077861-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077861-004	AP	1	`d8e5a09893c0…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBOPLATIN	CARBOPLATIN	Natco Pharma USA LLC	4c89cedc-e48b-445c-ad05-54dbe60e4fb0	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077861 application number: ANDA077861
CARBOPLATIN	CARBOPLATIN	Teyro Labs Private Limited	f64a0cbe-7fe3-407e-8933-21c30e1a1ebc	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077861 application number: ANDA077861
CARBOPLATIN	CARBOPLATIN	Apotex Corp.	1c275825-0275-4c73-b650-e4c1519f13b8	2024-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077861 application number: ANDA077861

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-239	CARBOPLATIN	CARBOPLATIN	Cipla USA Inc.	ANDA	Current
69097-241	CARBOPLATIN	CARBOPLATIN	Cipla USA Inc.	ANDA	Current
69097-242	CARBOPLATIN	CARBOPLATIN	Cipla USA Inc.	ANDA	Current
69097-243	CARBOPLATIN	CARBOPLATIN	Cipla USA Inc.	ANDA	Current