Application 205977

Type: ANDA
Sponsor: HETERO LABS LTD V

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
A205977-001	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2024-04-30
A205977-002	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2024-04-30
A205977-003	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2024-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205977-001	AB
A205977-002	AB
A205977-003	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	A205977-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2024-04-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205977-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2024-04-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205977-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2024-04-30	`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	A205977-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205977-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205977-003	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pitavastatin calcium	PITAVASTATIN CALCIUM	XLCare Pharmaceuticals Inc.	f29ea90c-f4e5-4f14-9660-a0404ef87f18	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205977 application number: ANDA205977
pitavastatin calcium	PITAVASTATIN CALCIUM	NorthStar RxLLC	98e3f1df-5b38-4169-a340-adb145eac459	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205977 application number: ANDA205977
pitavastatin calcium	PITAVASTATIN CALCIUM	Camber Pharmaceuticals, Inc.	e9622824-cee5-49d7-9273-f18b9cc176fd	2024-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205977 application number: ANDA205977

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75952	ORIG	2023-10-27