Application 215864

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCITONIN-SALMON	CALCITONIN SALMON	INJECTABLE;INJECTION	200 IU/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215864-001	CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/ML	INJECTABLE / INJECTION	AP		2026-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215864-001	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
2026-08-18 06:07:40	2026-07	A215864-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP		2026-03-04	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215864-001	CALCITONIN-SALMON	200 IU/ML	INJECTABLE / INJECTION	AP		2026-03-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215864-001	AP	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215864-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CALCITONIN SALMON	CALCITONIN SALMON	Zydus Lifesciences Limited	6a0fdcc3-9dca-4936-8601-9ec87457263d	2026-03-06		Exact identifier application applno (ANDA): 215864 application number: ANDA215864
CALCITONIN SALMON	CALCITONIN SALMON	Zydus Pharmaceuticals USA Inc.	0365ebf8-0cb6-49ce-bfde-707d42b9ab00	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215864 application number: ANDA215864