Application 213585

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	No	No
002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP		2020-07-16
A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP		2020-07-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213585-001	AP
A213585-002	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 1 of 2 · 76 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
2026-08-18 06:07:40	2026-07	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213585-001	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213585-002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-07-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213585-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213585-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213585-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213585-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213585-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213585-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213585-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213585-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213585-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213585-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213585-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213585-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213585-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213585-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213585-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213585-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213585-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213585-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213585-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213585-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213585-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213585-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213585-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213585-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213585-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213585-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213585-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213585-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213585-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213585-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213585-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213585-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213585-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213585-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213585-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213585-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213585-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213585-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213585-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213585-002	AP	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Milrinone Lactate in Dextrose	MILRINONE LACTATE IN DEXTROSE	Hospira, Inc.	5273ea17-6920-4bff-8c5b-20ea531a0423	2022-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213585 application number: ANDA213585 ndc (product): 0409-2045 ndc (product): 0409-1983
Milrinone Lactate in Dextrose	MILRINONE LACTATE	Gland Pharma Limited	838da14b-c070-4c09-b088-99e7c64d9964	2021-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213585 application number: ANDA213585 ndc (product): 68083-411 ndc (product): 68083-410
Milrinone Lactate in Dextrose	MILRINONE LACTATE	Sagent Pharmaceuticals	bb0157d0-a414-43fa-81e0-8c92d717f1b2	2020-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213585 application number: ANDA213585 ndc (product): 25021-313

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1983	Milrinone Lactate in Dextrose	Milrinone Lactate in Dextrose	Hospira, Inc.	ANDA	Current
0409-1983	Milrinone Lactate in Dextrose	Milrinone Lactate in Dextrose	Hospira, Inc.	ANDA	Current
0409-2045	Milrinone Lactate in Dextrose	Milrinone Lactate in Dextrose	Hospira, Inc.	ANDA	Current
25021-313	Milrinone Lactate in Dextrose	Milrinone Lactate	Sagent Pharmaceuticals	ANDA	Current
68083-410	Milrinone Lactate in Dextrose	Milrinone Lactate	Gland Pharma Limited	ANDA	Current
68083-410	Milrinone Lactate in Dextrose	Milrinone Lactate	Gland Pharma Limited	ANDA	Current
68083-411	Milrinone Lactate in Dextrose	Milrinone Lactate	Gland Pharma Limited	ANDA	Current
68083-411	Milrinone Lactate in Dextrose	Milrinone Lactate	Gland Pharma Limited	ANDA	Current