Application 206047

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	TABLET;ORAL	EQ 1MG BASE	No	No
002	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	TABLET;ORAL	EQ 2MG BASE	No	No
003	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	TABLET;ORAL	EQ 4MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A206047-001	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22
A206047-002	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22
A206047-003	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A206047-001	AB
A206047-002	AB
A206047-003	AB

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
2026-08-01 22:54:32	2026-06	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A206047-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206047-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206047-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
pitavastatin calcium	PITAVASTATIN CALCIUM	Zydus Lifesciences Limited	7b1a9aa6-a7a4-4050-8a40-89ba9728555a	2024-12-03		Exact identifier application applno (ANDA): 206047 application number: ANDA206047
pitavastatin calcium	PITAVASTATIN CALCIUM	Zydus Pharmaceuticals USA Inc.	c35e747e-10ac-4a76-bce6-187618fc64f9	2024-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206047 application number: ANDA206047