Home Applications 215212 Application 215212
Type NDA
Sponsor HQ SPCLT PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MEROPENEM MEROPENEM POWDER;INTRAVENOUS 2GM/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215212-001 MEROPENEM MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N215212-001 AP
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Documents# Document, Submission type, Date table Document Submission type Date 80520 SUPPL 2024-12-05 80501 SUPPL 2024-12-04 77824 ORIG 2024-03-14 74907 ORIG 2023-07-28 74908 ORIG 2023-07-27