Application 014103

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONCOVIN	VINCRISTINE SULFATE	INJECTABLE;INJECTION	1MG/VIAL	No	No
002	ONCOVIN	VINCRISTINE SULFATE	INJECTABLE;INJECTION	5MG/VIAL	No	No
003	ONCOVIN	VINCRISTINE SULFATE	INJECTABLE;INJECTION	1MG/ML	No	No

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

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	RLD / RS	Approval date
N014103-001	ONCOVIN	VINCRISTINE SULFATE	1MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N014103-002	ONCOVIN	VINCRISTINE SULFATE	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N014103-003	ONCOVIN	VINCRISTINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-07

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 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014103-002	ONCOVIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014103-003	ONCOVIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014103-001	ONCOVIN	1MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014103-002	ONCOVIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014103-003	ONCOVIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N014103-001	ONCOVIN	1MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N014103-002	ONCOVIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N014103-003	ONCOVIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014103-001	ONCOVIN	1MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014103-002	ONCOVIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014103-003	ONCOVIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N014103-001	ONCOVIN	1MG/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N014103-002	ONCOVIN	5MG/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N014103-003	ONCOVIN	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N014103-001	ONCOVIN	1MG/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N014103-002	ONCOVIN	5MG/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N014103-003	ONCOVIN	1MG/ML	INJECTABLE / INJECTION	RLD	1984-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N014103-001	ONCOVIN	1MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N014103-002	ONCOVIN	5MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N014103-003	ONCOVIN	1MG/ML	INJECTABLE / INJECTION		1984-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N014103-001	ONCOVIN	1MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014103-002	ONCOVIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014103-003	ONCOVIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014103-001	ONCOVIN	1MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014103-002	ONCOVIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014103-003	ONCOVIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-03-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014103-001	ONCOVIN	1MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014103-002	ONCOVIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014103-003	ONCOVIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-03-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N014103-001	ONCOVIN	1MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N014103-002	ONCOVIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N014103-003	ONCOVIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-03-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N014103-001	ONCOVIN	1MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N014103-002	ONCOVIN	5MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N014103-003	ONCOVIN	1MG/ML	INJECTABLE / INJECTION		1984-03-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N014103-001	ONCOVIN	1MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N014103-002	ONCOVIN	5MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N014103-003	ONCOVIN	1MG/ML	INJECTABLE / INJECTION		1984-03-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N014103-001	ONCOVIN	1MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N014103-002	ONCOVIN	5MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`

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
VinCRIStine Sulfate	VINCRISTINE SULFATE	Hospira, Inc.	b22e4c8e-dbe1-4d4b-a026-e1812974071c	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VINCRISTINE SULFATE
VinCRIStine Sulfate	VINCRISTINE SULFATE	Hospira, Inc.	49596de6-ab18-49d1-9e5b-30968fc21c36	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VINCRISTINE SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.