Application 215570

Type: ANDA
Sponsor: ZYDUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PALBOCICLIB	PALBOCICLIB	TABLET;ORAL	75MG	No	No
002	PALBOCICLIB	PALBOCICLIB	TABLET;ORAL	100MG	No	No
003	PALBOCICLIB	PALBOCICLIB	TABLET;ORAL	125MG	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	Approval date
A215570-001	PALBOCICLIB	PALBOCICLIB	75MG	TABLET / ORAL	2024-06-05
A215570-002	PALBOCICLIB	PALBOCICLIB	100MG	TABLET / ORAL	2024-06-05
A215570-003	PALBOCICLIB	PALBOCICLIB	125MG	TABLET / ORAL	2024-06-05

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 1 of 2 · 51 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
2026-02-19 14:30 UTC	2026-02	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL		2024-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL		2024-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL		2024-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL		2024-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL		2024-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL		2024-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL		2024-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL		2024-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL		2024-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL		2024-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL		2024-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL		2024-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL		2024-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL		2024-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL		2024-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL		2024-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL		2024-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL		2024-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL		2024-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL	AB	2024-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL	AB	2024-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL	AB	2024-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL	AB	2024-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL	AB	2024-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL	AB	2024-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL	AB	2024-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL	AB	2024-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL	AB	2024-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL	AB	2024-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL	AB	2024-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL	AB	2024-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL	AB	2024-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL	AB	2024-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL	AB	2024-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL	AB	2024-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215570-002	PALBOCICLIB	100MG	TABLET / ORAL	AB	2024-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215570-003	PALBOCICLIB	125MG	TABLET / ORAL	AB	2024-06-05	`1e350fbaab3a…`
2023-12-20 04:57 UTC	2023-12	A215570-001	PALBOCICLIB	75MG	TABLET / ORAL	AB	2023-08-28	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215570-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215570-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215570-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215570-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215570-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215570-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215570-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215570-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215570-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215570-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215570-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215570-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215570-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215570-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215570-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215570-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215570-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215570-003	AB	1	`1e350fbaab3a…`
2023-12-20 04:57 UTC	2023-12	A215570-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215570-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215570-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215570-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215570-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215570-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215570-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215570-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215570-003	AB	1	`9b2671bbb829…`

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
Ibrance	PALBOCICLIB	U.S. Pharmaceuticals	89a142d5-7e61-48bf-9e77-e2cd124c4792	2026-07-06	Warnings, Adverse reactions	Name fallback generic name: PALBOCICLIB
Ibrance	PALBOCICLIB	Pfizer Laboratories Div Pfizer Inc	fecbdd7d-b729-41b5-9872-231b8fe104ce	2026-07-02	Warnings, Adverse reactions	Name fallback generic name: PALBOCICLIB
Ibrance	PALBOCICLIB	Pfizer Laboratories Div Pfizer Inc	e0e6412f-50b4-4fd4-9364-62818d121a07	2026-07-02	Warnings, Adverse reactions	Name fallback generic name: PALBOCICLIB

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75397	ORIG	2023-09-12