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 42.

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 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14caaa826d4ba7…
2026-08-18 06:07:402026-07N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050630-001PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAMUSCULAR1990-12-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050630-002PRIMAXINEQ 750MG BASE/VIAL;750MG/VIALPOWDER / INTRAMUSCULAR1990-12-144b0b4de00fa7…
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…

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