Application 018057

Type: NDA
Sponsor: HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLATINOL	CISPLATIN	INJECTABLE;INJECTION	10MG/VIAL	Yes	No
002	PLATINOL	CISPLATIN	INJECTABLE;INJECTION	50MG/VIAL	Yes	No
003	PLATINOL-AQ	CISPLATIN	INJECTABLE;INJECTION	0.5MG/ML	Yes	No
004	CISPLATIN	CISPLATIN	INJECTABLE;INJECTION	1MG/ML	Yes	No

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

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	RLD / RS	Approval date
N018057-001	PLATINOL	CISPLATIN	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982
N018057-002	CISPLATIN	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N018057-003	PLATINOL-AQ	CISPLATIN	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18
N018057-004	CISPLATIN	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018057-004	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 · 172 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	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N018057-004	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018057-004	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018057-004	AP	1	`a50c72e98297…`

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
Cisplatin	CISPLATIN	WG Critical Care, LLC	508496cb-3441-46b3-a4fe-e0d440e6adc6	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018057 application number: NDA018057 ndc (product): 44567-530
CISplatin	CISPLATIN	WG Critical Care, LLC	2bf8d2fb-80c8-401d-8e9b-d58463f5e954	2021-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018057 application number: NDA018057 ndc (product): 44567-511 ndc (product): 44567-509 ndc (product): 44567-510

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-509	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-509	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-509	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-510	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-510	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-510	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-511	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-511	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-511	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-530	Cisplatin	cisplatin	WG Critical Care, LLC	NDA	Current
44567-530	Cisplatin	cisplatin	WG Critical Care, LLC	NDA	Current
44567-530	Cisplatin	cisplatin	WG Critical Care, LLC	NDA	Current
61126-003	Platinol	cisplatin	Corden Pharma Latina S.p.A.	NDA	Current
61126-004	Platinol-AQ	cisplatin	Corden Pharma Latina S.p.A.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71121	SUPPL	2022-05-23
57813	SUPPL	2019-02-27
57798	SUPPL	2019-02-25
11137	SUPPL	2015-03-02
14001	SUPPL	2015-02-27
33407	SUPPL	2012-01-11
14000	SUPPL	2012-01-03
13999	SUPPL	2011-08-31
11136	SUPPL	2011-08-30
11135	SUPPL	2010-09-07
816	SUPPL	2010-09-07
815	SUPPL	2002-11-08