FDA.reportPublic FDA data

Application 204824

Type
NDA
Sponsor
ANTARES PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS10MG/0.4ML (10MG/0.4ML)YesYes
002OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS15MG/0.4ML (15MG/0.4ML)YesYes
003OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS20MG/0.4ML (20MG/0.4ML)YesYes
004OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS25MG/0.4ML (25MG/0.4ML)YesYes
005OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS7.5MG/0.4ML (7.5MG/0.4ML)YesNo
006OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS12.5MG/0.4ML (12.5MG/0.4ML)YesYes
007OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS17.5MG/0.4ML (17.5MG/0.4ML)YesYes
008OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS22.5MG/0.4ML (22.5MG/0.4ML)YesYes
009OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS10MG/0.4ML (10MG/0.4ML)YesNo
010OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS15MG/0.6ML (15MG/0.6ML)YesNo
011OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS17.5MG/0.7ML (17.5MG/0.7ML)YesNo
012OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS20MG/0.8ML (20MG/0.8ML)YesNo
013OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS22.5MG/0.9ML (22.5MG/0.9ML)YesNo
014OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS25MG/ML (25MG/ML)YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 14 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204824-001OTREXUPMETHOTREXATE10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11
N204824-002OTREXUPMETHOTREXATE15MG/0.4ML (15MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11
N204824-003OTREXUPMETHOTREXATE20MG/0.4ML (20MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11
N204824-004OTREXUPMETHOTREXATE25MG/0.4ML (25MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11
N204824-005OTREXUPMETHOTREXATE7.5MG/0.4ML (7.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2014-11-07
N204824-006OTREXUPMETHOTREXATE12.5MG/0.4ML (12.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24
N204824-007OTREXUPMETHOTREXATE17.5MG/0.4ML (17.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24
N204824-008OTREXUPMETHOTREXATE22.5MG/0.4ML (22.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24
N204824-009OTREXUP PFSMETHOTREXATE10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31
N204824-010OTREXUP PFSMETHOTREXATE15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31
N204824-011OTREXUP PFSMETHOTREXATE17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31
N204824-012OTREXUP PFSMETHOTREXATE20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31
N204824-013OTREXUP PFSMETHOTREXATE22.5MG/0.9ML (22.5MG/0.9ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31
N204824-014OTREXUP PFSMETHOTREXATE25MG/ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31

Orange Book patents#

Current patent rows page 1 of 2 · 120 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204824-001114464412026-01-24Drug product2022-10-19
N204824-00185625642026-01-24Drug product2013-11-04
N204824-00195331022026-01-24Drug product2017-02-02
N204824-00196299592026-01-24Drug product2017-05-25
N204824-00180213352026-10-04Drug product2013-11-04
N204824-001107098442029-03-10Drug product2020-08-14
N204824-001116847232029-03-10Drug product2023-07-19
N204824-00198679492029-03-10Drug product2020-08-14
N204824-001114977532030-03-19Drug product2022-12-13
N204824-001123576422030-03-19Drug product2025-08-15
N204824-00184806312030-03-19U-1442Drug product2013-11-04
N204824-00185798652030-03-19U-1442Drug product2013-11-21
N204824-00189450632030-03-19U-1442Drug product2015-03-02
N204824-00194213332030-03-19U-1442Drug product2016-09-21
N204824-00188148342031-05-27Drug product2020-08-14
N204824-002114464412026-01-24Drug product2022-10-19
N204824-00285625642026-01-24Drug product2013-11-04
N204824-00295331022026-01-24Drug product2017-02-02
N204824-00296299592026-01-24Drug product2017-05-25
N204824-00280213352026-10-04Drug product2013-11-04
N204824-002107098442029-03-10Drug product2020-08-14
N204824-002116847232029-03-10Drug product2023-07-19
N204824-00298679492029-03-10Drug product2020-08-14
N204824-002114977532030-03-19Drug product2022-12-13
N204824-002123576422030-03-19Drug product2025-08-15
N204824-00284806312030-03-19U-1442Drug product
N204824-00285798652030-03-19U-1442Drug product2013-11-21
N204824-00289450632030-03-19U-1442Drug product2015-03-02
N204824-00294213332030-03-19U-1442Drug product2016-09-21
N204824-00288148342031-05-27Drug product2020-08-14
N204824-003114464412026-01-24Drug product2022-10-19
N204824-00385625642026-01-24Drug product2013-11-04
N204824-00395331022026-01-24Drug product2017-02-02
N204824-00396299592026-01-24Drug product2017-05-25
N204824-00380213352026-10-04Drug product2013-11-04
N204824-003107098442029-03-10Drug product2020-08-14
N204824-003116847232029-03-10Drug product2023-07-19
N204824-00398679492029-03-10Drug product2020-08-14
N204824-003114977532030-03-19Drug product2022-12-13
N204824-003123576422030-03-19Drug product2025-08-15
N204824-00384806312030-03-19U-1442Drug product
N204824-00385798652030-03-19U-1442Drug product2013-11-21
N204824-00389450632030-03-19U-1442Drug product2015-03-02
N204824-00394213332030-03-19U-1442Drug product2016-09-21
N204824-00388148342031-05-27Drug product2020-08-14
N204824-004114464412026-01-24Drug product2022-10-19
N204824-00485625642026-01-24Drug product2013-11-04
N204824-00495331022026-01-24Drug product2017-02-02
N204824-00496299592026-01-24Drug product2017-05-25
N204824-00480213352026-10-04Drug product2013-11-04
N204824-004107098442029-03-10Drug product2020-08-14
N204824-004116847232029-03-10Drug product2023-07-19
N204824-00498679492029-03-10Drug product2020-08-14
N204824-004114977532030-03-19Drug product2022-12-13
N204824-004123576422030-03-19Drug product2025-08-15
N204824-00484806312030-03-19U-1442Drug product
N204824-00485798652030-03-19U-1442Drug product2013-11-21
N204824-00489450632030-03-19U-1442Drug product2015-03-02
N204824-00494213332030-03-19U-1442Drug product2016-09-21
N204824-00488148342031-05-27Drug product2020-08-14
N204824-005114464412026-01-24Drug product2022-10-19
N204824-00585625642026-01-24Drug product2014-12-02
N204824-00595331022026-01-24Drug product2017-02-02
N204824-00596299592026-01-24Drug product2017-05-25
N204824-00580213352026-10-04Drug product2014-12-02
N204824-005107098442029-03-10Drug product2020-08-14
N204824-005116847232029-03-10Drug product2023-07-19
N204824-00598679492029-03-10Drug product2020-08-14
N204824-005114977532030-03-19Drug product2022-12-13
N204824-005123576422030-03-19Drug product2025-08-15
N204824-00584806312030-03-19U-1442Drug product2014-12-02
N204824-00585798652030-03-19U-1442Drug product2014-12-02
N204824-00589450632030-03-19U-1442Drug product2015-03-02
N204824-00594213332030-03-19U-1442Drug product2016-09-21
N204824-00588148342031-05-27Drug product2020-08-14
N204824-006114464412026-01-24Drug product2022-10-19
N204824-00685625642026-01-24Drug product2016-06-01
N204824-00695331022026-01-24Drug product2017-02-02
N204824-00696299592026-01-24Drug product2017-05-25
N204824-00680213352026-10-04Drug product2016-06-01

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 15 · 588 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N204824-001OTREXUP10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002OTREXUP15MG/0.4ML (15MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003OTREXUP20MG/0.4ML (20MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-004OTREXUP25MG/0.4ML (25MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-005OTREXUP7.5MG/0.4ML (7.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2014-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-006OTREXUP12.5MG/0.4ML (12.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-007OTREXUP17.5MG/0.4ML (17.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-008OTREXUP22.5MG/0.4ML (22.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-009OTREXUP PFS10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-010OTREXUP PFS15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-011OTREXUP PFS17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-012OTREXUP PFS20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-013OTREXUP PFS22.5MG/0.9ML (22.5MG/0.9ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-014OTREXUP PFS25MG/ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204824-001OTREXUP10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-002OTREXUP15MG/0.4ML (15MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-003OTREXUP20MG/0.4ML (20MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-004OTREXUP25MG/0.4ML (25MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-005OTREXUP7.5MG/0.4ML (7.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2014-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-006OTREXUP12.5MG/0.4ML (12.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-007OTREXUP17.5MG/0.4ML (17.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-008OTREXUP22.5MG/0.4ML (22.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-009OTREXUP PFS10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-010OTREXUP PFS15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-011OTREXUP PFS17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-012OTREXUP PFS20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-013OTREXUP PFS22.5MG/0.9ML (22.5MG/0.9ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-014OTREXUP PFS25MG/ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-001OTREXUP10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-002OTREXUP15MG/0.4ML (15MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-003OTREXUP20MG/0.4ML (20MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-004OTREXUP25MG/0.4ML (25MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-005OTREXUP7.5MG/0.4ML (7.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2014-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-006OTREXUP12.5MG/0.4ML (12.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-007OTREXUP17.5MG/0.4ML (17.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-008OTREXUP22.5MG/0.4ML (22.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-009OTREXUP PFS10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2017-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-010OTREXUP PFS15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2017-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-011OTREXUP PFS17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2017-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-012OTREXUP PFS20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2017-05-3131067a03dcf5…

Observed Orange Book patent history#

Patent history page 1 of 109 · 4,352 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N204824-001114464412026-01-24Drug product2022-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00185625642026-01-24Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00195331022026-01-24Drug product2017-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00196299592026-01-24Drug product2017-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00180213352026-10-04Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-001107098442029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-001116847232029-03-10Drug product2023-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00198679492029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-001114977532030-03-19Drug product2022-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-001123576422030-03-19Drug product2025-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00184806312030-03-19U-1442Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00185798652030-03-19U-1442Drug product2013-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00189450632030-03-19U-1442Drug product2015-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00194213332030-03-19U-1442Drug product2016-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00188148342031-05-27Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002114464412026-01-24Drug product2022-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00285625642026-01-24Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00295331022026-01-24Drug product2017-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00296299592026-01-24Drug product2017-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00280213352026-10-04Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002107098442029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002116847232029-03-10Drug product2023-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00298679492029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002114977532030-03-19Drug product2022-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002123576422030-03-19Drug product2025-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00284806312030-03-19U-1442Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00285798652030-03-19U-1442Drug product2013-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00289450632030-03-19U-1442Drug product2015-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00294213332030-03-19U-1442Drug product2016-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00288148342031-05-27Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003114464412026-01-24Drug product2022-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00385625642026-01-24Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00395331022026-01-24Drug product2017-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00396299592026-01-24Drug product2017-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00380213352026-10-04Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003107098442029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003116847232029-03-10Drug product2023-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00398679492029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003114977532030-03-19Drug product2022-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003123576422030-03-19Drug product2025-08-15caaa826d4ba7…

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
OtrexupMETHOTREXATEAntares Pharma, Inc.9ab8ce16-f7de-41d4-a4c8-1c742621b6d52025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 204824
application number: NDA204824
ndc (product): 54436-015
ndc (product): 54436-022
ndc (product): 54436-025
ndc (product): 54436-012
ndc (product): 54436-017
ndc (product): 54436-010
ndc (product): 54436-020

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61504SUPPL2020-01-02
61463SUPPL2019-12-27
59290ORIG2019-07-09
59289ORIG2019-07-09
59288ORIG2019-07-09
59136SUPPL2019-06-20
59129SUPPL2019-06-20
53062SUPPL2018-03-20
53044SUPPL2018-03-16
49087SUPPL2017-07-27
19606SUPPL2016-05-27
10402SUPPL2014-11-12
40426SUPPL2014-11-10
43480ORIG2014-02-03
19605ORIG2013-10-17
32597ORIG2013-10-16