Application 086530

Type
ANDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SECONAL SODIUMSECOBARBITAL SODIUMSUPPOSITORY;RECTAL30MGNoNo
002SECONAL SODIUMSECOBARBITAL SODIUMSUPPOSITORY;RECTAL60MGNoNo
003SECONAL SODIUMSECOBARBITAL SODIUMSUPPOSITORY;RECTAL120MGNoNo
004SECONAL SODIUMSECOBARBITAL SODIUMSUPPOSITORY;RECTAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A086530-001SECONAL SODIUMSECOBARBITAL SODIUM30MGSUPPOSITORY / RECTALApproved before 1982
A086530-002SECONAL SODIUMSECOBARBITAL SODIUM60MGSUPPOSITORY / RECTALApproved before 1982
A086530-003SECONAL SODIUMSECOBARBITAL SODIUM120MGSUPPOSITORY / RECTALApproved before 1982
A086530-004SECONAL SODIUMSECOBARBITAL SODIUM200MGSUPPOSITORY / RECTALApproved before 1982

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 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 198274a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.