Application 219170

Type: ANDA
Sponsor: CAPLIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MILRINONE LACTATE IN DEXTROSE 5%	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	No	No
002	MILRINONE LACTATE IN DEXTROSE 5%	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 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
A219170-001	MILRINONE LACTATE IN DEXTROSE 5%	MILRINONE LACTATE	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP		2025-09-02
A219170-002	MILRINONE LACTATE IN DEXTROSE 5%	MILRINONE LACTATE	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP		2025-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219170-001	AP
A219170-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A219170-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2025-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219170-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2025-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219170-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2025-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219170-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2025-09-02	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219170-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2025-09-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219170-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2025-09-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A219170-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219170-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219170-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219170-002	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219170-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219170-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Milrinone Lactate in 5% Dextrose	MILRINONE LACTATE IN 5% DEXTROSE	Caplin Steriles Limited	a2822b12-0560-49d6-ace5-2377c04425e8	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219170 application number: ANDA219170
Milrinone Lactate in 5% Dextrose	MILRINONE LACTATE IN 5% DEXTROSE	Somerset Therapeutics, LLC	27a19fc1-5e18-44e1-957d-d90f18dedc54	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219170 application number: ANDA219170