FDA.reportPublic FDA data

Application 062756

Type
ANDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRIMAXINCILASTATIN SODIUM; IMIPENEMINJECTABLE;INJECTIONEQ 250MG BASE/VIAL;250MG/VIALNoNo
002PRIMAXINCILASTATIN SODIUM; IMIPENEMINJECTABLE;INJECTIONEQ 500MG BASE/VIAL;500MG/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
A062756-001PRIMAXINCILASTATIN SODIUM; IMIPENEMEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08
A062756-002PRIMAXINCILASTATIN SODIUM; IMIPENEMEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08

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 06:07:402026-07A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08bb7c543d1eb4…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42775SUPPL2007-11-19
42774SUPPL2007-11-19
42773SUPPL2007-11-19
42763SUPPL2007-11-19
22290SUPPL2007-11-19
22289SUPPL2007-11-19
22288SUPPL2007-11-19
22284SUPPL2007-11-19
22274SUPPL2007-11-19
22272SUPPL2007-11-19
22271SUPPL2007-11-19
42772SUPPL2007-09-26
42771SUPPL2007-09-26
42770SUPPL2007-09-26
42769SUPPL2007-09-26
42768SUPPL2007-09-26
42767SUPPL2007-09-26
42766SUPPL2007-09-26
22287SUPPL2007-09-26
22286SUPPL2007-09-26
22285SUPPL2007-09-26
22283SUPPL2007-09-26
22281SUPPL2007-09-26
22280SUPPL2007-09-26
22279SUPPL2007-09-26
22278SUPPL2007-09-26
22277SUPPL2007-09-26
22276SUPPL2007-09-26
22282SUPPL2007-09-13
42765SUPPL2007-08-06
42764SUPPL2007-08-06
22275SUPPL2007-08-06
22273SUPPL2007-08-06