Application 211226

Type: NDA
Sponsor: ACROTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KHAPZORY	LEVOLEUCOVORIN	POWDER;INTRAVENOUS	175MG/VIAL	Yes	Yes
002	KHAPZORY	LEVOLEUCOVORIN	POWDER;INTRAVENOUS	300MG/VIAL	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211226-001	KHAPZORY	LEVOLEUCOVORIN	175MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2018-10-19
N211226-002	KHAPZORY	LEVOLEUCOVORIN	300MG/VIAL	POWDER / INTRAVENOUS		RLD	2018-10-19

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211226-001	11541012	2039-03-25		Drug product	2023-01-09
N211226-002	11541012	2039-03-25		Drug product	2023-01-09

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 3 · 82 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	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD	2018-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211226-001	KHAPZORY	175MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N211226-002	KHAPZORY	300MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-10-19	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 46 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	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211226-001	11541012	2039-03-25	Drug product	2023-01-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211226-002	11541012	2039-03-25	Drug product	2023-01-09	`a67488948f0b…`

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
KHAPZORY	LEVOLEUCOVORIN	Acrotech Biopharma Inc	344f65ac-9f04-49d7-b7c3-4ba19bd7b429	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211226 application number: NDA211226 ndc (product): 72893-004

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68152-112	KHAPZORY	levoleucovorin	Spectrum Pharmaceuticals, Inc.	NDA	Current
68152-112	KHAPZORY	levoleucovorin	Spectrum Pharmaceuticals, Inc.	NDA	Current
68152-112	KHAPZORY	levoleucovorin	Spectrum Pharmaceuticals, Inc.	NDA	Current
68152-114	KHAPZORY	levoleucovorin	Spectrum Pharmaceuticals, Inc.	NDA	Current
68152-114	KHAPZORY	levoleucovorin	Spectrum Pharmaceuticals, Inc.	NDA	Current
68152-114	KHAPZORY	levoleucovorin	Spectrum Pharmaceuticals, Inc.	NDA	Current
72893-004	KHAPZORY	levoleucovorin	Acrotech Biopharma LLC	NDA	Current
72893-004	KHAPZORY	levoleucovorin	Acrotech Biopharma LLC	NDA	Current
72893-006	KHAPZORY	levoleucovorin	Acrotech Biopharma LLC	NDA	Current
72893-006	KHAPZORY	levoleucovorin	Acrotech Biopharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62039	SUPPL	2020-03-05
62021	SUPPL	2020-03-04
57034	ORIG	2018-12-26
56081	ORIG	2018-10-23
56047	ORIG	2018-10-22