Application 021129

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEURONTINGABAPENTINSOLUTION;ORAL250MG/5MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021129-001NEURONTINGABAPENTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021129-001AA

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-023f01610625f2…
2019-09-15 20:21 UTC2019-09N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-023f0d92c62455…
2023-05-13 08:27 UTC2023-05N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02053a50430f4f…
2023-01-26 05:58 UTC2023-01N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021129-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021129-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021129-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021129-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021129-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021129-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021129-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021129-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021129-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021129-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021129-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021129-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021129-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021129-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021129-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021129-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021129-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021129-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021129-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021129-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021129-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03N021129-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021129-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021129-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021129-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N021129-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021129-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021129-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021129-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021129-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021129-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021129-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021129-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021129-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021129-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021129-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021129-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021129-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021129-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021129-001AA1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021129-00172562162022-05-28Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021129-0017256216*PED2022-11-28Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021129-00172562162022-05-28Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021129-0017256216*PED2022-11-28Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021129-00172562162022-05-28Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021129-0017256216*PED2022-11-28Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021129-00172562162022-05-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021129-0017256216*PED2022-11-28Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021129-00172562162022-05-28Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021129-0017256216*PED2022-11-28Pediatric extensionbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021129-00172562162022-05-28Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021129-0017256216*PED2022-11-28Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021129-00172562162022-05-28Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021129-0017256216*PED2022-11-28Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N021129-00172562162022-05-28Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021129-0017256216*PED2022-11-28Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021129-00172562162022-05-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021129-0017256216*PED2022-11-28Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021129-00172562162022-05-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021129-0017256216*PED2022-11-28Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021129-00172562162022-05-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021129-0017256216*PED2022-11-28Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021129-00172562162022-05-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021129-0017256216*PED2022-11-28Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021129-00172562162022-05-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021129-0017256216*PED2022-11-28Pediatric extensionea99ee380514…
2023-01-26 05:58 UTC2023-01N021129-00172562162022-05-28Drug product3bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021129-0017256216*PED2022-11-28Pediatric extension3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021129-00172562162022-05-28Drug product3a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021129-0017256216*PED2022-11-28Pediatric extension3a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021129-00172562162022-05-28Drug productf41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021129-0017256216*PED2022-11-28Pediatric extensionf41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021129-00172562162022-05-28Drug producte64feba35796…
2022-09-29 23:25 UTC2022-09N021129-0017256216*PED2022-11-28Pediatric extensione64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021129-00172562162022-05-28Drug productcb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021129-0017256216*PED2022-11-28Pediatric extensioncb3db0bc1861…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeurontinGABAPENTINViatris Specialty LLC97935fd9-1d4a-43b6-a5d9-de994591187b2026-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 021129
application number: NDA021129
GABAPENTINGABAPENTINMylan Pharmaceuticals Inc.cff7de45-148b-4e96-88fd-6052bf75b5f72025-04-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 021129
application number: NDA021129
ndc (product): 59762-5050
NeurontinGABAPENTINParke-Davis Div of Pfizer Incee9ad9ed-6d9f-4ee1-9d7f-cfad438df3882022-07-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 021129
application number: NDA021129
ndc (product): 0071-2012

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of PfizerNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5050GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5050GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5050GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5050GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82120SUPPL 2025-05-01
82070SUPPL 2025-04-29
82069SUPPL 2025-04-29
79111SUPPL 2024-07-18
79097SUPPL 2024-07-15
65668SUPPL2020-12-21
65667SUPPL2020-12-21
65636SUPPL2020-12-21
62534SUPPL2020-04-10
62434SUPPL2020-04-03
50124SUPPL2017-10-20
50103SUPPL2017-10-19
47752SUPPL2017-03-29
47715SUPPL2017-03-27
47714SUPPL2017-03-27
14451SUPPL2015-09-23
4402SUPPL2015-09-17
36169SUPPL2015-04-27
4403SUPPL2015-04-22
14450SUPPL2014-08-20
4401SUPPL2014-08-20
36168SUPPL2013-05-09
36167SUPPL2013-05-09
14449SUPPL2013-05-09
26842SUPPL2013-05-07
4400SUPPL2013-05-07
4399SUPPL2013-05-07
4398SUPPL2011-08-12
36166SUPPL2011-08-11
4397SUPPL2011-03-07
36165SUPPL2011-03-04
26841SUPPL2010-10-13
14448SUPPL2010-10-11
26840SUPPL2009-05-01
14447SUPPL2009-04-28
44100ORIG2008-02-01
4396SUPPL2006-05-05
26839SUPPL2005-02-23
14446SUPPL2005-02-23
4395SUPPL2004-06-10
41967SUPPL2004-05-06
21464ORIG2004-05-06
26838SUPPL2002-01-30