Application 207324

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBOPLATIN	CARBOPLATIN	INJECTABLE;IV (INFUSION)	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
A207324-001	CARBOPLATIN	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15
A207324-002	CARBOPLATIN	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15
A207324-003	CARBOPLATIN	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15
A207324-004	CARBOPLATIN	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207324-001	AP
A207324-002	AP
A207324-003	AP
A207324-004	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	A207324-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207324-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207324-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207324-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207324-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207324-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207324-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207324-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207324-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207324-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207324-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207324-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207324-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207324-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207324-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207324-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207324-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207324-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207324-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207324-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207324-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207324-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207324-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207324-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207324-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207324-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207324-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207324-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207324-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207324-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207324-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207324-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207324-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207324-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207324-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207324-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207324-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207324-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207324-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207324-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-02-15	`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	A207324-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207324-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207324-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207324-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207324-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207324-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207324-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207324-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207324-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207324-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207324-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207324-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207324-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207324-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207324-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207324-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207324-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207324-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207324-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207324-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207324-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207324-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207324-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207324-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207324-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207324-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207324-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207324-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207324-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207324-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207324-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207324-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207324-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207324-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207324-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207324-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207324-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207324-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207324-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207324-004	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 · 2 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	Exact identifier application applno (ANDA): 207324 application number: ANDA207324
CARBOPLATIN	CARBOPLATIN	Gland Pharma Limited	9eb057eb-29ce-40d2-9ac8-ed107f25f5ab	2023-11-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207324 application number: ANDA207324 ndc (product): 68083-191 ndc (product): 68083-190 ndc (product): 68083-193 ndc (product): 68083-192

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-603	CARBOPLATIN	Carboplatin	Alvogen Inc.	ANDA	Current
47781-604	CARBOPLATIN	Carboplatin	Alvogen Inc.	ANDA	Current
47781-605	CARBOPLATIN	Carboplatin	Alvogen Inc.	ANDA	Current
47781-606	CARBOPLATIN	Carboplatin	Alvogen Inc.	ANDA	Current
68083-190	CARBOPLATIN	Carboplatin	Gland Pharma Limited	ANDA	Current
68083-191	CARBOPLATIN	Carboplatin	Gland Pharma Limited	ANDA	Current
68083-192	CARBOPLATIN	Carboplatin	Gland Pharma Limited	ANDA	Current
68083-193	CARBOPLATIN	Carboplatin	Gland Pharma Limited	ANDA	Current