FDA.reportPublic FDA data

Application 202106

Type
NDA
Sponsor
B BRAUN MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINERMEROPENEMPOWDER;INTRAVENOUS500MG/VIALNoNo
002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINERMEROPENEMPOWDER;INTRAVENOUS1GM/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINERMEROPENEM500MG/VIALPOWDER / INTRAVENOUSRLD, RS2015-04-30
N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINERMEROPENEM1GM/VIALPOWDER / INTRAVENOUSRLD, RS2015-04-30

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202106-001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER500MG/VIALPOWDER / INTRAVENOUS2015-04-30782e0a99824c…
2021-12-28 21:50 UTC2021-12N202106-002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER1GM/VIALPOWDER / INTRAVENOUS2015-04-30782e0a99824c…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meropenem and Sodium ChlorideMEROPENEM AND SODIUM CHLORIDEB. Braun Medical Inc.3b952a55-6ef7-45c8-be21-16eefe37ec2e2025-08-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 202106
application number: NDA202106
ndc (product): 0264-3183
ndc (product): 0264-3185

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-3183Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3183Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3183Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3183Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3185Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3185Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3185Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3185Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80518SUPPL 2024-12-05
80495SUPPL 2024-12-04
62955SUPPL2020-05-13
62954SUPPL2020-05-13
62939SUPPL2020-05-13
51871SUPPL2018-01-26
51376SUPPL2018-01-22
44843ORIG2015-12-09
43384ORIG2015-12-09
40121ORIG2015-05-06
9961ORIG2015-05-05