Application 212436

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBRANCE	PALBOCICLIB	TABLET;ORAL	75MG	Yes	No
002	IBRANCE	PALBOCICLIB	TABLET;ORAL	100MG	Yes	No
003	IBRANCE	PALBOCICLIB	TABLET;ORAL	125MG	Yes	Yes

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	RLD / RS	Approval date
N212436-001	IBRANCE	PALBOCICLIB	75MG	TABLET / ORAL	RLD	2019-11-01
N212436-002	IBRANCE	PALBOCICLIB	100MG	TABLET / ORAL	RLD	2019-11-01
N212436-003	IBRANCE	PALBOCICLIB	125MG	TABLET / ORAL	RLD, RS	2019-11-01

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N212436-001	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26
N212436-001	RE47739*PED	2027-09-05	Pediatric extension
N212436-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27
N212436-001	10723730*PED	2034-08-08	Pediatric extension
N212436-001	11065250	2036-08-19	Drug product	2021-08-12
N212436-001	11065250*PED	2037-02-19	Pediatric extension
N212436-002	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26
N212436-002	RE47739*PED	2027-09-05	Pediatric extension
N212436-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27
N212436-002	10723730*PED	2034-08-08	Pediatric extension
N212436-002	11065250	2036-08-19	Drug product	2021-08-12
N212436-002	11065250*PED	2037-02-19	Pediatric extension
N212436-003	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26
N212436-003	RE47739*PED	2027-09-05	Pediatric extension
N212436-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27
N212436-003	10723730*PED	2034-08-08	Pediatric extension
N212436-003	11065250	2036-08-19	Drug product	2021-08-12
N212436-003	11065250*PED	2037-02-19	Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212436-001	M-14	2028-09-16
N212436-001	PED	2029-03-16
N212436-002	M-14	2028-09-16
N212436-002	PED	2029-03-16
N212436-003	M-14	2028-09-16
N212436-003	PED	2029-03-16

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 3 · 114 observed 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
2026-02-19 14:30 UTC	2026-02	N212436-001	IBRANCE	75MG	TABLET / ORAL		RLD	2019-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-002	IBRANCE	100MG	TABLET / ORAL		RLD	2019-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-003	IBRANCE	125MG	TABLET / ORAL		RLD, RS	2019-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-001	IBRANCE	75MG	TABLET / ORAL		RLD	2019-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-002	IBRANCE	100MG	TABLET / ORAL		RLD	2019-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-003	IBRANCE	125MG	TABLET / ORAL		RLD, RS	2019-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212436-001	IBRANCE	75MG	TABLET / ORAL		RLD	2019-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212436-002	IBRANCE	100MG	TABLET / ORAL		RLD	2019-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212436-003	IBRANCE	125MG	TABLET / ORAL		RLD, RS	2019-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212436-001	IBRANCE	75MG	TABLET / ORAL		RLD	2019-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212436-002	IBRANCE	100MG	TABLET / ORAL		RLD	2019-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212436-003	IBRANCE	125MG	TABLET / ORAL		RLD, RS	2019-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212436-001	IBRANCE	75MG	TABLET / ORAL		RLD	2019-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212436-002	IBRANCE	100MG	TABLET / ORAL		RLD	2019-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212436-003	IBRANCE	125MG	TABLET / ORAL		RLD, RS	2019-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212436-001	IBRANCE	75MG	TABLET / ORAL		RLD	2019-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212436-002	IBRANCE	100MG	TABLET / ORAL		RLD	2019-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212436-003	IBRANCE	125MG	TABLET / ORAL		RLD, RS	2019-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212436-001	IBRANCE	75MG	TABLET / ORAL		RLD	2019-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212436-002	IBRANCE	100MG	TABLET / ORAL		RLD	2019-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212436-003	IBRANCE	125MG	TABLET / ORAL		RLD, RS	2019-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212436-001	IBRANCE	75MG	TABLET / ORAL	AB	RLD	2019-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212436-002	IBRANCE	100MG	TABLET / ORAL	AB	RLD	2019-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212436-003	IBRANCE	125MG	TABLET / ORAL	AB	RLD, RS	2019-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212436-001	IBRANCE	75MG	TABLET / ORAL	AB	RLD	2019-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212436-002	IBRANCE	100MG	TABLET / ORAL	AB	RLD	2019-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212436-003	IBRANCE	125MG	TABLET / ORAL	AB	RLD, RS	2019-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212436-001	IBRANCE	75MG	TABLET / ORAL	AB	RLD	2019-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212436-002	IBRANCE	100MG	TABLET / ORAL	AB	RLD	2019-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212436-003	IBRANCE	125MG	TABLET / ORAL	AB	RLD, RS	2019-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212436-001	IBRANCE	75MG	TABLET / ORAL	AB	RLD	2019-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212436-002	IBRANCE	100MG	TABLET / ORAL	AB	RLD	2019-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212436-003	IBRANCE	125MG	TABLET / ORAL	AB	RLD, RS	2019-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212436-001	IBRANCE	75MG	TABLET / ORAL	AB	RLD	2019-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212436-002	IBRANCE	100MG	TABLET / ORAL	AB	RLD	2019-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212436-003	IBRANCE	125MG	TABLET / ORAL	AB	RLD, RS	2019-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212436-001	IBRANCE	75MG	TABLET / ORAL	AB	RLD	2019-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212436-002	IBRANCE	100MG	TABLET / ORAL	AB	RLD	2019-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212436-003	IBRANCE	125MG	TABLET / ORAL	AB	RLD, RS	2019-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212436-001	IBRANCE	75MG	TABLET / ORAL		RLD	2019-11-01	`8072bd15b7f6…`

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	N212436-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212436-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212436-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212436-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212436-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212436-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212436-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212436-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212436-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212436-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212436-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212436-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212436-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212436-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212436-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212436-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212436-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212436-003	AB	1	`1e350fbaab3a…`
2023-12-20 04:57 UTC	2023-12	N212436-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N212436-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N212436-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212436-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212436-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212436-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212436-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212436-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212436-003	AB	1	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 498 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212436-001	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-001	RE47739*PED	2027-09-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-001	10723730*PED	2034-08-08	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-001	11065250	2036-08-19	Drug product	2021-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-001	11065250*PED	2037-02-19	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-002	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-002	RE47739*PED	2027-09-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-002	10723730*PED	2034-08-08	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-002	11065250	2036-08-19	Drug product	2021-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-002	11065250*PED	2037-02-19	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-003	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-003	RE47739*PED	2027-09-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-003	10723730*PED	2034-08-08	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-003	11065250	2036-08-19	Drug product	2021-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-003	11065250*PED	2037-02-19	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-001	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-001	RE47739*PED	2027-09-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-001	10723730*PED	2034-08-08	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-001	11065250	2036-08-19	Drug product	2021-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-001	11065250*PED	2037-02-19	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-002	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-002	RE47739*PED	2027-09-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-002	10723730*PED	2034-08-08	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-002	11065250	2036-08-19	Drug product	2021-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-002	11065250*PED	2037-02-19	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-003	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-003	RE47739*PED	2027-09-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-003	10723730*PED	2034-08-08	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-003	11065250	2036-08-19	Drug product	2021-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-003	11065250*PED	2037-02-19	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212436-001	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212436-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212436-001	11065250	2036-08-19	Drug product	2021-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212436-002	RE47739	2027-03-05	Drug substance, Drug product	2019-11-26	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212436-001	M-14	2028-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-001	PED	2029-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-002	M-14	2028-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-002	PED	2029-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-003	M-14	2028-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212436-003	PED	2029-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-001	M-14	2028-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-001	PED	2029-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-002	M-14	2028-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-002	PED	2029-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-003	M-14	2028-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212436-003	PED	2029-03-16	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	N212436-001	NCE	2020-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212436-002	NCE	2020-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212436-003	NCE	2020-02-03	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N212436-001	NCE	2020-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212436-002	NCE	2020-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212436-003	NCE	2020-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212436-001	NCE	2020-02-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N212436-002	NCE	2020-02-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N212436-003	NCE	2020-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N212436-001	NCE	2020-02-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N212436-002	NCE	2020-02-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N212436-003	NCE	2020-02-03	`3f01610625f2…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212436-001	M-14	2028-09-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212436-001	PED	2029-03-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212436-002	M-14	2028-09-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212436-002	PED	2029-03-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212436-003	M-14	2028-09-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212436-003	PED	2029-03-16	`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
Ibrance	PALBOCICLIB	U.S. Pharmaceuticals	89a142d5-7e61-48bf-9e77-e2cd124c4792	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212436 application number: NDA212436 ndc (product): 63539-486 ndc (product): 63539-688 ndc (product): 63539-284
Ibrance	PALBOCICLIB	Pfizer Laboratories Div Pfizer Inc	fecbdd7d-b729-41b5-9872-231b8fe104ce	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212436 application number: NDA212436 ndc (product): 0069-0486 ndc (product): 0069-0284 ndc (product): 0069-0688

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0284	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0284	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0284	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0284	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0486	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0486	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0486	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0486	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0688	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0688	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0688	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0688	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
63539-284	Ibrance	palbociclib	US Pharmaceuticals	NDA	Current
63539-284	Ibrance	palbociclib	US Pharmaceuticals	NDA	Current
63539-284	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-486	Ibrance	palbociclib	US Pharmaceuticals	NDA	Current
63539-486	Ibrance	palbociclib	US Pharmaceuticals	NDA	Current
63539-486	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-688	Ibrance	palbociclib	US Pharmaceuticals	NDA	Current
63539-688	Ibrance	palbociclib	US Pharmaceuticals	NDA	Current
63539-688	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83376	SUPPL	2025-09-18
83374	SUPPL	2025-09-17
82092	SUPPL	2025-05-01
81968	SUPPL	2025-04-24
81507	SUPPL	2025-03-10
81478	SUPPL	2025-03-07
80747	SUPPL	2024-12-27
80710	SUPPL	2024-12-26
75367	SUPPL	2023-09-07
75366	SUPPL	2023-09-07
75361	SUPPL	2023-09-07
75360	SUPPL	2023-09-07
72881	SUPPL	2022-12-14
72878	SUPPL	2022-12-14
62443	ORIG	2020-04-06
60784	ORIG	2019-11-12
60778	ORIG	2019-11-04