Home Applications 040331 Application 040331
Type ANDA
Sponsor EPIC PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE TABLET;ORAL 50MG No Yes 002 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE TABLET;ORAL 100MG No Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040331-001 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 A040331-002 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040331-001 AA
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 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 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1999-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1999-05-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1999-05-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 1999-05-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1999-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1999-05-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 bb7c543d1eb4…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42806-050 Meperidine Hydrochloride Meperidine Hydrochloride EPIC PHARMA, LLC ANDA Current 42806-050 Meperidine Hydrochloride Meperidine Hydrochloride EPIC PHARMA, LLC ANDA Current 42806-050 Meperidine Hydrochloride Meperidine Hydrochloride EPIC PHARMA, LLC ANDA Current 42806-051 Meperidine Hydrochloride Meperidine Hydrochloride EPIC PHARMA, LLC ANDA Current 42806-051 Meperidine Hydrochloride Meperidine Hydrochloride EPIC PHARMA, LLC ANDA Current 42806-051 Meperidine Hydrochloride Meperidine Hydrochloride EPIC PHARMA, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76297 ORIG 2023-11-03 7626 ORIG 1999-05-28