Home Applications 040624 Application 040624
Type ANDA
Sponsor VINTAGE PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE TABLET;ORAL 2.5MG No No 002 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE TABLET;ORAL 5MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040624-001 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 A040624-002 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040624-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2006-12-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040624-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2006-12-28 782e0a99824c…
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 · 7 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE Bryant Ranch Prepack 4ee28ed4-daff-462c-a38b-4fd8250ed9f4 2026-06-30 Warnings, Adverse reactions Name fallback brand name: METHSCOPOLAMINE BROMIDE generic name: METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE Bryant Ranch Prepack 6b8ed187-d378-4c95-80e0-0d3558a7aa95 2026-03-13 Warnings, Adverse reactions Name fallback brand name: METHSCOPOLAMINE BROMIDE generic name: METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE PD-Rx Pharmaceuticals, Inc. 26cd56db-4727-40d1-8f08-3ee899052c77 2026-01-05 Warnings, Adverse reactions Name fallback brand name: METHSCOPOLAMINE BROMIDE generic name: METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE PD-Rx Pharmaceuticals, Inc. 8a14ade6-d428-4144-9037-46955f68820f 2026-01-05 Warnings, Adverse reactions Name fallback brand name: METHSCOPOLAMINE BROMIDE generic name: METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE Unichem Pharmaceuticals (USA), Inc. 5c74bfb0-c80a-4a86-acd1-1e3a1b20255d 2025-12-10 Warnings, Adverse reactions Name fallback brand name: METHSCOPOLAMINE BROMIDE generic name: METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE i3 Pharmaceuticals, LLC 14c0c030-e96d-4a5e-95ff-02dd78a46be3 2025-02-24 Warnings, Adverse reactions Name fallback brand name: METHSCOPOLAMINE BROMIDE generic name: METHSCOPOLAMINE BROMIDE Methscopolamine Bromide METHSCOPOLAMINE BROMIDE Breckenridge Pharmaceutical, Inc. 157c1cce-bceb-4c74-8aa0-d2be9952d8f9 2024-01-10 Warnings, Adverse reactions Name fallback brand name: Methscopolamine Bromide generic name: METHSCOPOLAMINE BROMIDE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 64376-603 Methscopolamine Bromide Methscopolamine Bromide Par Pharmaceutical ANDA Current 64376-603 Methscopolamine Bromide Methscopolamine Bromide Par Pharmaceutical ANDA Current 64376-604 Methscopolamine Bromide Methscopolamine Bromide Par Pharmaceutical ANDA Current 64376-604 Methscopolamine Bromide Methscopolamine Bromide Par Pharmaceutical ANDA Current