Application 086358

Type: ANDA
Sponsor: BRISTOL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEXATE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/VIAL	No	No
002	MEXATE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 50MG BASE/VIAL	No	No
003	MEXATE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL	No	No
004	MEXATE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS
A086358-001	MEXATE	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982
A086358-002	MEXATE	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982
A086358-003	MEXATE	METHOTREXATE SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982
A086358-004	MEXATE	METHOTREXATE SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A086358-001	MEXATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086358-002	MEXATE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086358-003	MEXATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086358-004	MEXATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086358-001	MEXATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086358-002	MEXATE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086358-003	MEXATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086358-004	MEXATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086358-001	MEXATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086358-002	MEXATE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086358-003	MEXATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086358-004	MEXATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086358-001	MEXATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086358-002	MEXATE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086358-003	MEXATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086358-004	MEXATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086358-001	MEXATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086358-002	MEXATE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086358-003	MEXATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086358-004	MEXATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086358-001	MEXATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086358-002	MEXATE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086358-003	MEXATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086358-004	MEXATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086358-001	MEXATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086358-002	MEXATE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086358-003	MEXATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086358-004	MEXATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086358-001	MEXATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086358-002	MEXATE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086358-003	MEXATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086358-004	MEXATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086358-001	MEXATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A086358-002	MEXATE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A086358-003	MEXATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A086358-004	MEXATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086358-001	MEXATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A086358-002	MEXATE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A086358-003	MEXATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A086358-004	MEXATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate Sodium	METHOTREXATE SODIUM	Elite Laboratories, Inc.	89c05ea3-3be1-46dd-b112-29c436fd7289	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Sun Pharmaceutical Industries, Inc.	8f1260de-b60c-4f0e-8af6-0e957b0a281b	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate Sodium	METHOTREXATE SODIUM	Hikma Pharmaceuticals USA Inc.	d71b1856-99d8-4a9e-9189-f87b6675f80a	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Fresenius Kabi USA, LLC	ec476b11-0b3c-4139-b1eb-a3daa76bc271	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Bryant Ranch Prepack	c7592288-ac24-46c6-8cec-9abe23d7e81e	2023-12-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Fresenius Kabi USA, LLC	b585f621-f6c9-4735-ab61-bd1b401f3df0	2021-03-24	Boxed warning, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM

Reported adverse events (FAERS/openFDA)#

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