Application 062750

Type
ANDA
Sponsor
WYETH PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIPRACILPIPERACILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo
002PIPRACILPIPERACILLIN SODIUMINJECTABLE;INJECTIONEQ 3GM BASE/VIALNoNo
003PIPRACILPIPERACILLIN SODIUMINJECTABLE;INJECTIONEQ 4GM BASE/VIALNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062750-001PIPRACILPIPERACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-13
A062750-002PIPRACILPIPERACILLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-13
A062750-003PIPRACILPIPERACILLIN SODIUMEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-13

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-1387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-1387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-135aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-135aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12A062750-003PIPRACILEQ 4GM BASE/VIALINJECTABLE / INJECTION1987-10-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062750-001PIPRACILEQ 2GM BASE/VIALINJECTABLE / INJECTION1987-10-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11A062750-002PIPRACILEQ 3GM BASE/VIALINJECTABLE / INJECTION1987-10-13c0c555d07b60…

Reported adverse events (FAERS/openFDA)#

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