Home Applications 203550 Application 203550
Type ANDA
Sponsor DBL PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHOCARBAMOL METHOCARBAMOL TABLET;ORAL 500MG No No 002 METHOCARBAMOL METHOCARBAMOL TABLET;ORAL 750MG 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 A203550-001 METHOCARBAMOL METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 A203550-002 METHOCARBAMOL METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-8435 METHOCARBAMOL METHOCARBAMOL NCS HealthCare of KY, LLC dba Vangard Labs ANDA Current 0615-8436 METHOCARBAMOL METHOCARBAMOL NCS HealthCare of KY, LLC dba Vangard Labs ANDA Current 17511-505 METHOCARBAMOL METHOCARBAMOL RA CHEM PHARMA LIMITED ANDA Current 17511-506 METHOCARBAMOL METHOCARBAMOL RA CHEM PHARMA LIMITED ANDA Current 70934-322 METHOCARBAMOL METHOCARBAMOL Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-322 METHOCARBAMOL METHOCARBAMOL Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 71093-140 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-140 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-140 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-140 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-140 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-140 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-141 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-141 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-141 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-141 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-141 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current 71093-141 METHOCARBAMOL METHOCARBAMOL ACI Healthcare USA, Inc. ANDA Current