FDA.reportPublic FDA data

Application 022020

Type
NDA
Sponsor
WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROTONIXPANTOPRAZOLE SODIUMFOR SUSPENSION, DELAYED RELEASE;ORALEQ 40MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022020-001PROTONIXPANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14

Therapeutic equivalence codes#

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

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

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022020-00175443702026-06-07Drug product
N022020-0017544370*PED2026-12-07Pediatric 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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N022020-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N022020-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022020-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022020-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022020-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022020-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022020-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022020-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022020-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022020-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022020-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022020-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022020-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022020-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022020-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022020-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022020-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022020-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022020-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N022020-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022020-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022020-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022020-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022020-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022020-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022020-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022020-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022020-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022020-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022020-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022020-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022020-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022020-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022020-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022020-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022020-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022020-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022020-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022020-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 8 · 311 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022020-00175443702026-06-07Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022020-0017544370*PED2026-12-07Pediatric extension84e616aacf4f…
2026-08-18 06:07:402026-07N022020-00175443702026-06-07Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022020-0017544370*PED2026-12-07Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022020-00175443702026-06-07Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022020-0017544370*PED2026-12-07Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022020-00175501532024-09-30U-85931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022020-00175534982024-09-30U-85931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022020-00178380272024-09-30U-859Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022020-0017550153*PED2025-03-30Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022020-0017553498*PED2025-03-30Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022020-0017838027*PED2025-03-30Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022020-00175443702026-06-07Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022020-0017544370*PED2026-12-07Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N022020-0017550153*PED2025-03-30Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022020-0017553498*PED2025-03-30Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022020-0017838027*PED2025-03-30Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022020-00175443702026-06-07Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022020-0017544370*PED2026-12-07Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022020-0017550153*PED2025-03-30Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022020-0017553498*PED2025-03-30Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022020-0017838027*PED2025-03-30Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022020-00175443702026-06-07Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022020-0017544370*PED2026-12-07Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022020-0017550153*PED2025-03-30Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022020-0017553498*PED2025-03-30Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022020-0017838027*PED2025-03-30Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022020-00175443702026-06-07Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022020-0017544370*PED2026-12-07Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022020-00175501532024-09-30U-85903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022020-00175534982024-09-30U-85903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022020-00178380272024-09-30U-859Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022020-0017550153*PED2025-03-30Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022020-0017553498*PED2025-03-30Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022020-0017838027*PED2025-03-30Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022020-00175443702026-06-07Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022020-0017544370*PED2026-12-07Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022020-00175501532024-09-30U-8592680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022020-00175534982024-09-30U-8592680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022020-00178380272024-09-30U-859Drug product2680178bc6a6…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protonix Delayed-ReleasePANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.08098cb2-c048-4640-f387-6beec4a389362026-05-18Warnings, Adverse reactionsExact 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-0844ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0844ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0844ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0844ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
55154-4232Protonixpantoprazole sodiumCardinal HealthNDACurrent
55154-4232Protonixpantoprazole sodiumCardinal Health 107, LLCNDACurrent
55154-4232Protonixpantoprazole sodiumCardinal HealthNDACurrent
55154-4232Protonixpantoprazole sodiumCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74814SUPPL 2023-07-20
74813SUPPL 2023-07-20
74794SUPPL 2023-07-19
70447SUPPL2022-03-09
70446SUPPL2022-03-09
70422SUPPL2022-03-07
65419SUPPL2020-11-30
65418SUPPL2020-11-30
65378SUPPL2020-11-30
60232SUPPL2019-10-04
60228SUPPL2019-10-04
58447SUPPL2019-04-26
58446SUPPL2019-04-26
58438SUPPL2019-04-26
54570SUPPL2018-06-14
54505SUPPL2018-06-11
50878SUPPL2017-12-27
50839SUPPL2017-12-22
48956SUPPL2017-07-12
48955SUPPL2017-07-12
48939SUPPL2017-07-10
45717SUPPL2016-10-31
45659SUPPL2016-10-26
38092SUPPL2014-12-29
29090SUPPL2014-12-24
29089SUPPL2013-12-13
16780SUPPL2013-12-11
16778SUPPL2012-10-15
29088SUPPL2012-10-11
16779SUPPL2012-05-15
23690ORIG2011-12-20
38091SUPPL2011-11-01
6697SUPPL2011-10-31
16777SUPPL2011-05-25
6698SUPPL2011-05-25
16776SUPPL2010-09-10
6696SUPPL2010-09-08
29087SUPPL2009-11-25
38090SUPPL2009-11-16
44664ORIG2009-03-31
42387ORIG2009-03-31
38089ORIG2007-11-19
6695ORIG2007-11-19
64042ORIG1900-01-01
64041ORIG1900-01-01
64040ORIG1900-01-01
64039ORIG1900-01-01
64038ORIG1900-01-01
58111ORIG1900-01-01
54079ORIG1900-01-01
53382ORIG1900-01-01
53381ORIG1900-01-01
53380ORIG1900-01-01
53379ORIG1900-01-01
53378ORIG1900-01-01