Application 215813

Type: NDA
Sponsor: MERIDIAN LABORATORIES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	10MG/ML	No	No
002	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	20MG/2ML	No	No
003	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	80MG/8ML	No	No
004	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	160MG/16ML	No	No

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

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
N215813-001	DOCIVYX	DOCETAXEL	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22
N215813-002	DOCIVYX	DOCETAXEL	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22
N215813-003	DOCIVYX	DOCETAXEL	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N215813-001	10398785	2036-03-14	Drug product	2023-07-07
N215813-002	10398785	2036-03-14	Drug product	2023-07-07
N215813-003	10398785	2036-03-14	Drug product	2023-07-07

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 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215813-002	DOCIVYX	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215813-003	DOCIVYX	160MG/16ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215813-001	DOCIVYX	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-11-22	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215813-002	10398785	2036-03-14	Drug product	2023-07-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215813-003	10398785	2036-03-14	Drug product	2023-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215813-001	10398785	2036-03-14	Drug product	2023-07-07	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOCIVYX	DOCETAXEL	Avyxa Pharma, LLC	4763744e-360e-4d37-be05-cce4114548cd	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215813 application number: NDA215813

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80907	SUPPL	2025-02-04
78125	SUPPL	2024-04-12
78124	SUPPL	2024-04-12
78119	SUPPL	2024-04-12
78118	SUPPL	2024-04-12
74899	ORIG	2023-07-27
72717	ORIG	2022-11-25
72673	ORIG	2022-11-23