Home Applications 078912 Application 078912
Type ANDA
Sponsor PERRIGO R AND D Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GUAIFENESIN GUAIFENESIN TABLET, EXTENDED RELEASE;ORAL 600MG No No 002 GUAIFENESIN GUAIFENESIN TABLET, EXTENDED RELEASE;ORAL 1.2GM No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A078912-001 GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2011-11-23 A078912-002 GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2020-11-05
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 3 of 3 · 83 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 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078912-002 GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2020-11-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078912-001 GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2011-11-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078912-002 GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2020-11-05 a50c72e98297…
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 2 · 27 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-2023 good sense mucus er guaifenesin L. Perrigo Company ANDA Current 0113-2023 good sense mucus er guaifenesin L. Perrigo Company ANDA Current 0615-7712 Guaifenesin Extended Release Guaifenesin NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 11673-421 up and up mucus relief guaifenesin Target Corporation ANDA Current 11673-421 up and up mucus relief guaifenesin Target Corporation ANDA Current 11822-2123 mucus relief guaifenesin Rite Aid Corporation ANDA Current 41250-684 mucus relief Guaifenesin Meijer Distribution Inc ANDA Current 41250-684 mucus relief Guaifenesin Meijer Distribution Inc ANDA Current 41250-684 mucus relief Guaifenesin Meijer Distribution Inc ANDA Current 49035-498 Equate Mucus ER Guaifenesin Wal-Mart Stores Inc ANDA Current 55910-310 DG Health Mucus ER Guaifenesin Dolgencorp Inc ANDA Current 64024-222 welby mucus relief guaifenesin Aldi Inc ANDA Current 64024-222 welby mucus relief guaifenesin Aldi Inc ANDA Current 69842-806 mucus guaifenesin CVS Pharmacy ANDA Current 72288-298 basic care mucus er Guaifenesin Amazon.com Services LLC ANDA Current 72288-298 basic care mucus er Guaifenesin Amazon.com Services LLC ANDA Current 72288-298 basic care mucus er Guaifenesin Amazon.com Services LLC ANDA Current 72288-298 basic care mucus er Guaifenesin Amazon.com Services LLC ANDA Current 76162-123 Topcare mucus er guaifenesin Topco Associates LLC ANDA Current 81522-006 caring mill mucus er guaifenesin FSA Store Inc. ANDA Current