Application 022020

Type: NDA
Sponsor: WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROTONIX	PANTOPRAZOLE SODIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 40MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022020-001	PROTONIX	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022020-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022020-001	7544370	2026-06-07		Drug product
N022020-001	7544370*PED	2026-12-07		Pediatric extension

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 · 44 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
2026-10-15 13:18:30	2026-09	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD, RS	2007-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD, RS	2007-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD, RS	2007-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD, RS	2007-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N022020-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022020-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022020-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022020-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022020-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022020-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022020-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022020-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022020-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022020-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022020-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022020-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022020-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022020-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022020-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022020-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022020-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022020-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022020-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022020-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022020-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022020-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022020-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022020-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022020-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022020-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022020-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022020-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022020-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022020-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022020-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022020-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022020-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022020-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022020-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022020-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 4 of 8 · 313 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-04-04 05:41 UTC	2022-04	N022020-001	7553498	2024-09-30	U-859		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022020-001	7838027	2024-09-30	U-859	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022020-001	7544370	2026-06-07		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022020-001	7550153	2024-09-30	U-859		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022020-001	7553498	2024-09-30	U-859		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022020-001	7838027	2024-09-30	U-859	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022020-001	7544370	2026-06-07		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022020-001	7550153	2024-09-30	U-859		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022020-001	7553498	2024-09-30	U-859		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022020-001	7838027	2024-09-30	U-859	Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022020-001	7544370	2026-06-07		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022020-001	7550153	2024-09-30	U-859		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022020-001	7553498	2024-09-30	U-859		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022020-001	7838027	2024-09-30	U-859	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022020-001	7544370	2026-06-07		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	7550153	2024-09-30	U-859		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	7553498	2024-09-30	U-859		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	7838027	2024-09-30	U-859	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	7544370	2026-06-07		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022020-001	7550153	2024-09-30	U-859		`5aa47cf7b7d7…`

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
Protonix Delayed-Release	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	08098cb2-c048-4640-f387-6beec4a38936	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022020 application number: NDA022020 ndc (product): 0008-0844

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0008-0844	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-0844	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-0844	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-0844	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
55154-4232	Protonix	pantoprazole sodium	Cardinal Health	NDA	Current
55154-4232	Protonix	pantoprazole sodium	Cardinal Health 107, LLC	NDA	Current
55154-4232	Protonix	pantoprazole sodium	Cardinal Health	NDA	Current
55154-4232	Protonix	pantoprazole sodium	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74814	SUPPL	2023-07-20
74813	SUPPL	2023-07-20
74794	SUPPL	2023-07-19
70447	SUPPL	2022-03-09
70446	SUPPL	2022-03-09
70422	SUPPL	2022-03-07
65419	SUPPL	2020-11-30
65418	SUPPL	2020-11-30
65378	SUPPL	2020-11-30
60232	SUPPL	2019-10-04
60228	SUPPL	2019-10-04
58447	SUPPL	2019-04-26
58446	SUPPL	2019-04-26
58438	SUPPL	2019-04-26
54570	SUPPL	2018-06-14
54505	SUPPL	2018-06-11
50878	SUPPL	2017-12-27
50839	SUPPL	2017-12-22
48956	SUPPL	2017-07-12
48955	SUPPL	2017-07-12
48939	SUPPL	2017-07-10
45717	SUPPL	2016-10-31
45659	SUPPL	2016-10-26
38092	SUPPL	2014-12-29
29090	SUPPL	2014-12-24
29089	SUPPL	2013-12-13
16780	SUPPL	2013-12-11
16778	SUPPL	2012-10-15
29088	SUPPL	2012-10-11
16779	SUPPL	2012-05-15
23690	ORIG	2011-12-20
38091	SUPPL	2011-11-01
6697	SUPPL	2011-10-31
16777	SUPPL	2011-05-25
6698	SUPPL	2011-05-25
16776	SUPPL	2010-09-10
6696	SUPPL	2010-09-08
29087	SUPPL	2009-11-25
38090	SUPPL	2009-11-16
44664	ORIG	2009-03-31
42387	ORIG	2009-03-31
38089	ORIG	2007-11-19
6695	ORIG	2007-11-19
64042	ORIG	1900-01-01
64041	ORIG	1900-01-01
64040	ORIG	1900-01-01
64039	ORIG	1900-01-01
64038	ORIG	1900-01-01
58111	ORIG	1900-01-01
54079	ORIG	1900-01-01
53382	ORIG	1900-01-01
53381	ORIG	1900-01-01
53380	ORIG	1900-01-01
53379	ORIG	1900-01-01
53378	ORIG	1900-01-01