FDA.reportPublic FDA data

Application 050630

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRIMAXINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAMUSCULAREQ 500MG BASE/VIAL;500MG/VIALNoNo
002PRIMAXINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAMUSCULAREQ 750MG BASE/VIAL;750MG/VIALNoNo

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
N050630-001PRIMAXINCILASTATIN SODIUM; IMIPENEMEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14
N050630-002PRIMAXINCILASTATIN SODIUM; IMIPENEMEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14

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 UTC2019-12N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14782e0a99824c…
2021-12-28 21:50 UTC2021-12N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-1487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-145aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-148869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-143f01610625f2…
2019-12-14 00:12 UTC2019-12N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-143f01610625f2…
2019-09-15 20:21 UTC2019-09N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-146a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-141c564ffb4f44…
2024-02-18 07:12 UTC2024-02N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-149b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-143f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14053a50430f4f…
2023-05-13 08:27 UTC2023-05N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-143bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-143a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-143a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30194SUPPL2009-11-25
39055SUPPL2009-09-22
30193SUPPL2008-12-19
42660SUPPL2008-08-11
22170SUPPL2008-08-11
22169SUPPL2008-08-11
7909SUPPL2008-04-02
39054SUPPL2008-04-01
42663SUPPL2008-02-19
42662SUPPL2008-02-19
22171SUPPL2008-02-19
30192SUPPL2007-03-31
17955SUPPL2007-03-31
7908SUPPL2006-08-07
7907SUPPL2004-05-26
30191SUPPL2003-03-10
30190SUPPL2001-11-30
42661SUPPL1999-02-04