Application 202111

Type: ANDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	INJECTABLE;INJECTION	100MG	No	No
002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	INJECTABLE;INJECTION	500MG	No	No
003	PEMETREXED DISODIUM	PEMETREXED DISODIUM	POWDER;INTRAVENOUS	EQ 1GM 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A202111-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2022-05-25
A202111-002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-05-25
A202111-003	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	2022-05-25

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 3 · 96 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
2023-01-26 05:58 UTC	2023-01	A202111-003	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS		2022-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202111-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202111-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202111-003	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202111-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202111-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202111-003	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202111-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202111-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202111-003	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202111-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202111-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202111-003	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202111-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS		2022-05-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202111-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS		2022-05-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202111-003	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS		2022-05-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202111-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202111-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202111-003	AP	1	`5c6f7cd8ea54…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202111-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202111-002	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202111-003	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202111-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202111-002	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202111-003	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202111-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202111-002	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202111-003	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202111-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202111-002	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202111-003	AP	1	`cb3db0bc1861…`

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
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Senores Pharmaceuticals, Inc.	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2023-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202111 application number: ANDA202111 ndc (product): 82012-027

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
82012-027	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	Senores Pharmaceuticals, Inc.	ANDA	Current