Application 062888

Type
ANDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRINCIPENAMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALEQ 250MG BASENoNo
002PRINCIPENAMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALEQ 500MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A062888-001PRINCIPENAMPICILLIN/AMPICILLIN TRIHYDRATEEQ 250MG BASECAPSULE / ORAL1988-03-04
A062888-002PRINCIPENAMPICILLIN/AMPICILLIN TRIHYDRATEEQ 500MG BASECAPSULE / ORAL1988-03-04

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 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-04782e0a99824c…
2021-12-28 21:50 UTC2021-12A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-0487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-045aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-048869cabd3fbd…
2020-12-22 03:56 UTC2020-12A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-04c0c555d07b60…
2020-11-12 02:37 UTC2020-11A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-043f01610625f2…
2019-12-14 00:12 UTC2019-12A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-043f01610625f2…
2019-09-15 20:21 UTC2019-09A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-04b00525d2431f…
2019-09-15 20:21 UTC2019-09A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-04ea99ee380514…
2019-07-19 19:46 UTC2019-07A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-046a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-041c564ffb4f44…
2024-02-18 07:12 UTC2024-02A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-04ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-04a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-049b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-04a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-043f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-04053a50430f4f…
2023-05-13 08:27 UTC2023-05A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-043bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062888-001PRINCIPENEQ 250MG BASECAPSULE / ORAL1988-03-043a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062888-002PRINCIPENEQ 500MG BASECAPSULE / ORAL1988-03-043a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

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