Application 219981

Type: ANDA
Sponsor: CAPLIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	INJECTABLE;INJECTION	0.004MG/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A219981-001	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP		2026-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219981-001	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	RLD / RS	Approval date	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219981-001	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE / INJECTION	AP		2026-02-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219981-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desmopressin Acetate	DESMOPRESSIN ACETATE	Armas Pharmaceuticals Inc.	d87168b9-f103-4ba5-b0b3-0656d1c81da2	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219981 application number: ANDA219981
Desmopressin Acetate	DESMOPRESSIN ACETATE	Armas Pharmaceuticals Inc.	673cd9ab-b714-49ee-9ce7-c99be605c30e	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219981 application number: ANDA219981
Desmopressin Acetate	DESMOPRESSIN ACETATE	Caplin Steriles Limited	84dbb392-4535-4cbc-af60-75abb494f26e	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219981 application number: ANDA219981