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 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
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 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 UTC2019-12A062756-001PRIMAXINEQ 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…
2021-12-28 21:50 UTC2021-12A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-0887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-085aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-088869cabd3fbd…
2020-12-22 03:56 UTC2020-12A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08c0c555d07b60…
2020-11-12 02:37 UTC2020-11A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-083f01610625f2…
2019-12-14 00:12 UTC2019-12A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-083f01610625f2…
2019-09-15 20:21 UTC2019-09A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08b00525d2431f…
2019-09-15 20:21 UTC2019-09A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08ea99ee380514…
2019-07-19 19:46 UTC2019-07A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-086a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-081c564ffb4f44…
2024-02-18 07:12 UTC2024-02A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-089b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-083f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-08053a50430f4f…
2023-05-13 08:27 UTC2023-05A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-083bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062756-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALINJECTABLE / INJECTION1987-01-083a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062756-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALINJECTABLE / INJECTION1987-01-083a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

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

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