FDA.reportPublic FDA data

Application 210618

Type
ANDA
Sponsor
SLAYBACK PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATESOLUTION;INTRAMUSCULAR1250MG/5ML (250MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-283f01610625f2…
2019-09-15 20:21 UTC2019-09A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-28ea99ee380514…
2023-01-26 05:58 UTC2023-01A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210618-001HYDROXYPROGESTERONE CAPROATE1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP12018-12-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210618-001AP115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210618-001AP115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210618-001AP114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210618-001AP1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210618-001AP11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210618-001AP11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210618-001AP1187673890dc5c…
2021-03-12 10:30 UTC2021-03A210618-001AP115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210618-001AP118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210618-001AP11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210618-001AP113f01610625f2…
2019-09-15 20:21 UTC2019-09A210618-001AP11b00525d2431f…
2019-07-19 19:46 UTC2019-07A210618-001AP11ea99ee380514…
2023-01-26 05:58 UTC2023-01A210618-001AP113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210618-001AP113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210618-001AP11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210618-001AP11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210618-001AP11cb3db0bc1861…

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
Hydroxyprogesterone CaproateHYDROXYPROGESTERONE CAPROATEEugia US LLC687bcf42-f437-42c7-8909-a91f621f55df2026-06-12Warnings, Adverse reactionsName fallback
brand name: Hydroxyprogesterone Caproate
generic name: HYDROXYPROGESTERONE CAPROATE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71225-104HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATESlayback Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57276ORIG2019-01-18