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 44.

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086530-001SECONAL SODIUM30MGSUPPOSITORY / RECTALApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086530-002SECONAL SODIUM60MGSUPPOSITORY / RECTALApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086530-003SECONAL SODIUM120MGSUPPOSITORY / RECTALApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086530-004SECONAL SODIUM200MGSUPPOSITORY / RECTALApproved before 19823a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

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