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 44.

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 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14c2088c7a36db…
2026-09-14 22:38:342026-08N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-1484e616aacf4f…
2026-08-18 06:07:402026-07N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALRLD, RS2007-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALRLD, RS2007-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALRLD, RS2007-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALRLD, RS2007-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022020-001PROTONIXEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALABRLD, RS2007-11-143a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N022020-001AB1c2088c7a36db…
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 5 of 8 · 313 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2021-03-12 10:30 UTC2021-03N022020-00175534982024-09-30U-8595aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022020-00178380272024-09-30U-859Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022020-0017550153*PED2025-03-30Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022020-0017553498*PED2025-03-30Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022020-0017838027*PED2025-03-30Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022020-00175443702026-06-07Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022020-0017544370*PED2026-12-07Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022020-00175501532024-09-30U-8598869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022020-00175534982024-09-30U-8598869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022020-00178380272024-09-30U-859Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022020-0017550153*PED2025-03-30Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022020-0017553498*PED2025-03-30Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022020-0017838027*PED2025-03-30Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022020-00175443702026-06-07Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022020-0017544370*PED2026-12-07Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022020-00175501532024-09-30U-859c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022020-00175534982024-09-30U-859c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022020-00178380272024-09-30U-859Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022020-0017550153*PED2025-03-30Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022020-0017553498*PED2025-03-30Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022020-0017838027*PED2025-03-30Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022020-00175443702026-06-07Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022020-0017544370*PED2026-12-07Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N022020-00175501532024-09-30U-8593f01610625f2…
2019-12-14 00:12 UTC2019-12N022020-00175534982024-09-30U-8593f01610625f2…
2019-12-14 00:12 UTC2019-12N022020-00178380272024-09-30U-859Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022020-0017550153*PED2025-03-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N022020-0017553498*PED2025-03-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N022020-0017838027*PED2025-03-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N022020-00175443702026-06-07Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022020-0017544370*PED2026-12-07Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N022020-00175501532024-09-30U-859b00525d2431f…
2019-09-15 20:21 UTC2019-09N022020-00175534982024-09-30U-859b00525d2431f…
2019-09-15 20:21 UTC2019-09N022020-00178380272024-09-30U-859Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022020-0017550153*PED2025-03-30Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N022020-0017553498*PED2025-03-30Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N022020-0017838027*PED2025-03-30Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N022020-00175443702026-06-07Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022020-0017544370*PED2026-12-07Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N022020-00175501532024-09-30U-859ea99ee380514…

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