Application 201529

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	No	No
002	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	No	No
003	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	No	No
004	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	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	TE codes	Approval date
A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29
A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29
A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29
A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A201529-001	AP
A201529-002	AP
A201529-003	AP
A201529-004	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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-03-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201529-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201529-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201529-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201529-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-03-29	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A201529-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201529-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201529-003	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201529-004	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201529-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201529-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201529-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201529-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201529-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201529-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201529-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201529-004	AP	1	`caaa826d4ba7…`
2019-12-13 00:20 UTC	2019-12	A201529-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201529-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201529-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201529-004	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201529-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201529-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201529-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201529-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201529-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201529-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201529-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201529-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201529-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201529-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201529-003	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201529-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201529-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201529-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201529-003	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201529-004	AP	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201529-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201529-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201529-003	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201529-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHOTREXATE	METHOTREXATE	Eugia US LLC	63bb6fbf-dd59-4edc-af8f-d0c397ca1262	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201529 application number: ANDA201529

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-466	Methotrexate	Methotrexate	Mylan Institutional LLC	ANDA	Current
67457-466	Methotrexate	Methotrexate	Mylan Institutional LLC	ANDA	Current
67457-466	Methotrexate	Methotrexate	Mylan Institutional LLC	ANDA	Current