Application 206136

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIROXICAMPIROXICAMCAPSULE;ORAL10MGNoNo
002PIROXICAMPIROXICAMCAPSULE;ORAL20MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206136-001PIROXICAMPIROXICAM10MGCAPSULE / ORAL2017-06-20
A206136-002PIROXICAMPIROXICAM20MGCAPSULE / ORAL2017-06-20

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206136-001PIROXICAM10MGCAPSULE / ORAL2017-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206136-002PIROXICAM20MGCAPSULE / ORAL2017-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206136-001PIROXICAM10MGCAPSULE / ORALAB2017-06-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A206136-002PIROXICAM20MGCAPSULE / ORALAB2017-06-20782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206136-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206136-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206136-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206136-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206136-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206136-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206136-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206136-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206136-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206136-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206136-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206136-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206136-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206136-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206136-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206136-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206136-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206136-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206136-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206136-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206136-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206136-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206136-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206136-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206136-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206136-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206136-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206136-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206136-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206136-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206136-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206136-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206136-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206136-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206136-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206136-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206136-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206136-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206136-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206136-002AB187673890dc5c…

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
PiroxicamPIROXICAMProficient Rx LP23972bf0-e5b8-4f4b-97d0-caa05d6b061c2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206136
application number: ANDA206136
ndc (product): 71205-032

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42543-114PiroxicamPiroxicamVensun Pharmaceuticals, Inc.ANDACurrent
42543-114PiroxicamPiroxicamVensun Pharmaceuticals, Inc.ANDACurrent
42543-115PiroxicamPiroxicamVensun Pharmaceuticals, Inc.ANDACurrent
42543-115PiroxicamPiroxicamVensun Pharmaceuticals, Inc.ANDACurrent
71205-032PiroxicamPiroxicamProficient Rx LPANDACurrent
71205-032PiroxicamPiroxicamProficient Rx LPANDACurrent