Application 207103

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBRANCE	PALBOCICLIB	CAPSULE;ORAL	75MG	Yes	No
002	IBRANCE	PALBOCICLIB	CAPSULE;ORAL	100MG	Yes	No
003	IBRANCE	PALBOCICLIB	CAPSULE;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
N207103-001	IBRANCE	PALBOCICLIB	75MG	CAPSULE / ORAL	RLD	2015-02-03
N207103-002	IBRANCE	PALBOCICLIB	100MG	CAPSULE / ORAL	RLD	2015-02-03
N207103-003	IBRANCE	PALBOCICLIB	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19
N207103-001	RE47739*PED	2027-09-05	Pediatric extension
N207103-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27
N207103-001	10723730*PED	2034-08-08	Pediatric extension
N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19
N207103-002	RE47739*PED	2027-09-05	Pediatric extension
N207103-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27
N207103-002	10723730*PED	2034-08-08	Pediatric extension
N207103-003	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19
N207103-003	RE47739*PED	2027-09-05	Pediatric extension
N207103-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27
N207103-003	10723730*PED	2034-08-08	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
N207103-001	M-14	2028-09-16
N207103-001	PED	2029-03-16
N207103-002	M-14	2028-09-16
N207103-002	PED	2029-03-16
N207103-003	M-14	2028-09-16
N207103-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 549 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	N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-001	RE47739*PED	2027-09-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-001	10723730*PED	2034-08-08	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	RE47739*PED	2027-09-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	10723730*PED	2034-08-08	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	RE47739*PED	2027-09-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	10723730*PED	2034-08-08	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	RE47739*PED	2027-09-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	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	N207103-001	10723730*PED	2034-08-08	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	RE47739*PED	2027-09-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	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	N207103-002	10723730*PED	2034-08-08	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	RE47739*PED	2027-09-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	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	N207103-003	10723730*PED	2034-08-08	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-003	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-003	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207103-001	M-14	2028-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-001	PED	2029-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	M-14	2028-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	PED	2029-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	M-14	2028-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	PED	2029-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	M-14	2028-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	PED	2029-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	M-14	2028-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	PED	2029-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	M-14	2028-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	PED	2029-03-16	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	N207103-001	I-725	2019-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207103-001	NCE	2020-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207103-002	I-725	2019-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207103-002	NCE	2020-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207103-003	I-725	2019-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207103-003	NCE	2020-02-03	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N207103-001	NCE	2020-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207103-002	NCE	2020-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207103-003	NCE	2020-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207103-001	NCE	2020-02-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207103-002	NCE	2020-02-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207103-003	NCE	2020-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207103-001	I-725	2019-02-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207103-001	NCE	2020-02-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207103-002	I-725	2019-02-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207103-002	NCE	2020-02-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207103-003	I-725	2019-02-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207103-003	NCE	2020-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207103-001	I-725	2019-02-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207103-001	NCE	2020-02-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207103-002	I-725	2019-02-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207103-002	NCE	2020-02-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207103-003	I-725	2019-02-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207103-003	NCE	2020-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207103-001	I-725	2019-02-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207103-001	NCE	2020-02-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207103-002	I-725	2019-02-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207103-002	NCE	2020-02-03	`ea99ee380514…`

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
Ibrance	PALBOCICLIB	Pfizer Laboratories Div Pfizer Inc	e0e6412f-50b4-4fd4-9364-62818d121a07	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207103 application number: NDA207103 ndc (product): 0069-0188 ndc (product): 0069-0187 ndc (product): 0069-0189

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0187	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0187	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0187	Ibrance	palbociclib	Pfizer Laboratories Div P	NDA	Current
0069-0187	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0187	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0188	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0188	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0188	Ibrance	palbociclib	Pfizer Laboratories Div P	NDA	Current
0069-0188	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0188	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0189	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0189	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0189	Ibrance	palbociclib	Pfizer Laboratories Div P	NDA	Current
0069-0189	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0189	Ibrance	palbociclib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
63539-187	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-187	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-187	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-187	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-187	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-188	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-188	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-188	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-188	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-188	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-189	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-189	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-189	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-189	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current
63539-189	Ibrance	palbociclib	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83375	SUPPL	2025-09-18
83373	SUPPL	2025-09-17
82091	SUPPL	2025-05-01
81967	SUPPL	2025-04-24
81506	SUPPL	2025-03-10
81477	SUPPL	2025-03-07
80746	SUPPL	2024-12-27
80708	SUPPL	2024-12-26
75365	SUPPL	2023-09-07
75364	SUPPL	2023-09-07
75359	SUPPL	2023-09-07
75358	SUPPL	2023-09-07
72880	SUPPL	2022-12-14
72877	SUPPL	2022-12-14
60747	SUPPL	2019-10-31
59977	SUPPL	2019-10-28
59978	SUPPL	2019-09-11
59956	SUPPL	2019-09-10
59955	SUPPL	2019-09-10
59618	SUPPL	2019-08-07
58221	SUPPL	2019-04-05
58218	SUPPL	2019-04-04
57776	SUPPL	2019-02-22
57706	SUPPL	2019-02-20
52658	SUPPL	2018-02-15
52535	SUPPL	2018-02-09
52495	SUPPL	2018-02-07
47847	SUPPL	2017-04-03
47817	SUPPL	2017-04-03
10612	SUPPL	2016-02-22
19957	SUPPL	2016-02-19
44956	ORIG	2015-03-13
23031	ORIG	2015-03-13
32845	ORIG	2015-02-04
40583	ORIG	2015-02-03