Application 205955

Type: ANDA
Sponsor: SAWAI USA

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 44.

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
A205955-001	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03
A205955-002	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03
A205955-003	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205955-001	AB
A205955-002	AB
A205955-003	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.

Product history page 2 of 4 · 132 observed 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205955-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205955-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205955-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-03	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A205955-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205955-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205955-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205955-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205955-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205955-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205955-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205955-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205955-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205955-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205955-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205955-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205955-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205955-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205955-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205955-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205955-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205955-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205955-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205955-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205955-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205955-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205955-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205955-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205955-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205955-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205955-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205955-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205955-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205955-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205955-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205955-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205955-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205955-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205955-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205955-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205955-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205955-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205955-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205955-001	AB	1	`79d66fd596c7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pitavastatin	PITAVASTATIN CALCIUM	Upsher-Smith Laboratories, LLC	9ad1ecb9-822d-47c1-9f6f-6f771fa0f924	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205955 application number: ANDA205955

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.