Home Applications 075077 Application 075077
Type ANDA
Sponsor PERRIGO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ACETAMINOPHEN ACETAMINOPHEN TABLET, EXTENDED RELEASE;ORAL 650MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A075077-001 ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE / ORAL 2000-02-25
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 A075077-001 ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE / ORAL 2000-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075077-001 ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE / ORAL 2000-02-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075077-001 ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE / ORAL 2000-02-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075077-001 ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE / ORAL 2000-02-25 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 · 28 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 3 · 174 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0044 Good Sense Pain Relief Acetaminophen L. Perrigo Company ANDA Current 0113-0044 Good Sense Pain Relief Acetaminophen L. Perrigo Company ANDA Current 0113-0044 Good Sense Pain Relief Acetaminophen L. Perrigo Company ANDA Current 0113-0217 good sense pain relief Acetaminophen L. Perrigo Company ANDA Current 0113-0217 good sense pain relief Acetaminophen L. Perrigo Company ANDA Current 0113-0544 good sense pain relief Acetaminophen L. Perrigo Company ANDA Current 0113-0544 good sense pain relief Acetaminophen L. Perrigo Company ANDA Current 0113-0544 good sense pain relief Acetaminophen L. Perrigo Company ANDA Current 0113-7544 Basic Care Acetaminophen Acetaminophen L. Perrigo Company ANDA Current 0113-7544 Basic Care Acetaminophen Acetaminophen L. Perrigo Company ANDA Current 0113-7544 Basic Care Acetaminophen Acetaminophen L. Perrigo Company ANDA Current 0280-8090 Midol Long Lasting Relief Acetaminophen Bayer HealthCare LLC. ANDA Current 0280-8090 Midol Long Lasting Relief Acetaminophen Bayer HealthCare LLC. ANDA Current 0280-8090 Midol Long Lasting Relief Acetaminophen Bayer HealthCare LLC. ANDA Current 0280-8090 Midol Long Lasting Relief Acetaminophen Bayer HealthCare LLC. ANDA Current 0280-8090 Midol Long Lasting Relief Acetaminophen Bayer HealthCare LLC. ANDA Current 0363-0544 arthritis pain reliever Acetaminophen Walgreen Company ANDA Current 0363-0544 arthritis pain reliever Acetaminophen Walgreen Company ANDA Current 0363-0544 arthritis pain reliever Acetaminophen Walgreen Company ANDA Current 0615-7590 Acetaminophen Extended Release Acetaminophen NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-7590 Acetaminophen Extended Release Acetaminophen NCS HealthCare of KY, LLC dba Vangard Labs ANDA Current 0615-7590 Acetaminophen Extended Release Acetaminophen NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0904-5769 mapap arthritis pain Acetaminophen Major Pharmaceuticals ANDA Current 0904-5769 mapap arthritis pain Acetaminophen Major Pharmaceuticals ANDA Current 0904-5769 mapap arthritis pain Acetaminophen Major Pharmaceuticals ANDA Current 0904-6883 major acetaminophen Acetaminophen Major Pharmaceuticals ANDA Current 0904-6883 major acetaminophen Acetaminophen Major Pharmaceuticals ANDA Current 0904-6883 major acetaminophen Acetaminophen Major Pharmaceuticals ANDA Current 11673-210 Up and Up Arthritis Pain Relief Acetaminophen Target Corporation ANDA Current 11673-210 Up and Up Arthritis Pain Relief Acetaminophen Target Corporation ANDA Current 11673-544 up and up temporary minor arthritis pain relief Acetaminophen Target Corporation ANDA Current 11673-618 Up and Up acetaminophen Acetaminophen Target Corporation ANDA Current 11673-618 Up and Up acetaminophen Acetaminophen Target Corporation ANDA Current 11673-966 up and up acetaminophen Acetaminophen Target Corporation ANDA Current 11673-966 up and up acetaminophen Acetaminophen Target Corporation ANDA Current 11822-0217 acetaminophen Acetaminophen Rite Aid Corporation ANDA Current 11822-0217 acetaminophen Acetaminophen Rite Aid Corporation ANDA Current 11822-0544 Acetaminophen Acetaminophen Rite Aid Corporation ANDA Current 11822-0631 Acetaminophen Acetaminophen Rite Aid Corporation ANDA Current 11822-0631 Acetaminophen Acetaminophen Rite Aid Corporation ANDA Current 24385-629 good neighbor pharmacy pain relief Acetaminophen Amerisource Bergen ANDA Current 24385-629 good neighbor pharmacy pain relief Acetaminophen Amerisource Bergen ANDA Current 30142-119 Acetaminophen Acetaminophen Kroger Company ANDA Current 30142-119 Acetaminophen Acetaminophen Kroger Company ANDA Current 30142-313 acetaminophen Acetaminophen Kroger Company ANDA Current 30142-544 arthritis pain relief Acetaminophen Kroger Company ANDA Current 30142-544 arthritis pain relief Acetaminophen Kroger Company ANDA Current 30142-789 arthritis pain acetaminophen Kroger Company ANDA Current 30142-789 arthritis pain acetaminophen Kroger Company ANDA Current 30142-792 arthritis pain acetaminophen Kroger Company ANDA Current 30142-966 arthritis pain relief Acetaminophen Kroger Company ANDA Current 30142-966 arthritis pain relief Acetaminophen Kroger Company ANDA Current 30142-966 arthritis pain relief Acetaminophen Kroger Company ANDA Current 36800-369 Topcare 8 Hour Pain Relief Acetaminophen Topco Associates LLC ANDA Current 36800-369 Topcare 8 Hour Pain Relief Acetaminophen Topco Associates LLC ANDA Current 36800-369 Topcare 8 Hour Pain Relief Acetaminophen Topco Associates LLC ANDA Current 36800-369 Topcare 8 Hour Pain Relief Acetaminophen Topco Associates LLC ANDA Current 36800-369 Topcare 8 Hour Pain Relief Acetaminophen Topco Associates LLC ANDA Current 36800-404 topcare arthritis pain Acetaminophen Topco Associates LLC ANDA Current 36800-404 topcare arthritis pain Acetaminophen Topco Associates LLC ANDA Current 36800-455 topcare 8 hr arthritis pain relief Acetaminophen Topco Associates LLC ANDA Current 36800-455 topcare 8 hr arthritis pain relief Acetaminophen Topco Associates LLC ANDA Current 36800-455 topcare 8 hr arthritis pain relief Acetaminophen Topco Associates LLC ANDA Current 36800-544 Topcare Arthritis Pain Relief Acetaminophen Topco Associates LLC ANDA Current 36800-779 topcare 8 hr arthritis pain relief Acetaminophen Topco Associates LLC ANDA Current 36800-779 topcare 8 hr arthritis pain relief Acetaminophen Topco Associates LLC ANDA Current 36800-779 topcare 8 hr arthritis pain relief Acetaminophen Topco Associates LLC ANDA Current 37012-544 Arthritis Pain Acetaminophen Shopko Stores Operating Co., LLC ANDA Current 37012-544 Arthritis Pain Acetaminophen Shopko Stores Operating Co., LLC ANDA Current 37808-455 Pain Relief Acetaminophen H E B ANDA Current 37808-455 Pain Relief Acetaminophen H E B ANDA Current 37808-747 Pain Relief 8 HR Acetaminophen H E B ANDA Current 37808-747 Pain Relief 8 HR Acetaminophen H E B ANDA Current 37808-747 Pain Relief 8 HR Acetaminophen H E B ANDA Current 41163-544 equaline arthritis Acetaminophen Supervalu Inc ANDA Current 41190-544 ShopRite Arthritis Pain Acetaminophen Wakefern Food Corporation ANDA Current 41250-544 arthritis pain relief Acetaminophen Meijer Distribution Inc ANDA Current 41250-544 arthritis pain relief Acetaminophen Meijer Distribution Inc ANDA Current 41250-544 arthritis pain relief Acetaminophen Meijer Distribution Inc ANDA Current 41250-544 arthritis pain relief Acetaminophen Meijer Distribution Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22414 ORIG 2001-06-07 30750 ORIG 2000-02-25