FDA.reportPublic FDA data

Application 076200

Type
ANDA
Sponsor
OHM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHENACETAMINOPHENTABLET, EXTENDED RELEASE;ORAL650MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076200-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENMedline Industries, LP9f18d455-55ce-482c-8da8-dcb664038c6c2026-04-10WarningsExact identifier
application applno (ANDA): 076200
application number: ANDA076200
ndc (product): 53329-643

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 2 · 88 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0334AcetaminophenAcetaminophenWalgreen CompanyANDACurrent
0363-0336AcetaminophenAcetaminophenWalgreen CompanyANDACurrent
0363-0336AcetaminophenAcetaminophenWalgreen CompanyANDACurrent
0363-0336AcetaminophenAcetaminophenWalgreen CompanyANDACurrent
0615-8404Arthritis Pain RelieverAcetaminophenNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8404Arthritis Pain RelieverAcetaminophenNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8404Arthritis Pain RelieverAcetaminophenNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
15127-332AcetaminophenAcetaminophenSelect BrandANDACurrent
21130-336Arthritis 8 HourAcetaminophenSafeway Inc.ANDACurrent
21130-760AcetaminophenAcetaminophenSafeway Inc.ANDACurrent
21130-760AcetaminophenAcetaminophenSafeway Inc.ANDACurrent
30142-968AcetaminophenACETAMINOPHENThe Kroger CompanyANDACurrent
30142-968AcetaminophenACETAMINOPHENThe Kroger CompanyANDACurrent
30142-968AcetaminophenACETAMINOPHENThe Kroger CompanyANDACurrent
30142-970Arthritis Pain RelieverAcetaminophenThe Kroger CompanyANDACurrent
33261-665Arthritis Pain RelieverAcetaminophenAidarex Pharmaceuticals LLCANDACurrent
36800-228Topco Arthritis 8 HourAcetaminophenTopco Associates LLCANDACurrent
37012-333AcetaminophenAcetaminophenShopko Stores Operating Co., LLCANDACurrent
37205-034Leader Arthritis Pain RelieverAcetaminophenCardinal HealthANDACurrent
37205-477Leader 8 Hour Pain RelieverAcetaminophenCardinal HealthANDACurrent
37808-333AcetaminophenAcetaminophenH-E-BANDACurrent
41163-333AcetaminophenAcetaminophenSUPERVALU INC.ANDACurrent
41163-336Acetaminophen 8 HourAcetaminophenSupervalu Inc.ANDACurrent
41520-333AcetaminophenAcetaminophenAmerican Sales CompanyANDACurrent
41520-336Acetaminophen-APAP 8 HourAcetaminophenAmerican Sales CompanyANDACurrent
46122-062AcetaminophenAcetaminophenAmerisource BergenANDACurrent
46122-062AcetaminophenAcetaminophenAmerisource BergenANDACurrent
46122-062AcetaminophenAcetaminophenAmerisource BergenANDACurrent
46122-062AcetaminophenAcetaminophenAmerisource BergenANDACurrent
46122-062AcetaminophenAcetaminophenAmerisource BergenANDACurrent
46122-170AcetaminophenAcetaminophenAmerisource BergenANDACurrent
46122-170AcetaminophenAcetaminophenAmerisource BergenANDACurrent
49348-921Sunmark Arthritis Pain RelieverAcetaminophenSunmarkANDACurrent
49348-924Sunmark Arthritis 8 HourAcetaminophenSunmarkANDACurrent
49614-473Medicine Shoppe Arthritis Pain RelieverAcetaminophenThe Medicine Shoppe InternationalANDACurrent
50268-052Arthritis Pain RelieverAcetaminophenAvPAKANDACurrent
50268-052Arthritis Pain RelieverAcetaminophenAvPAKANDACurrent
50268-052Arthritis Pain RelieverAcetaminophenAvPAKANDACurrent
51660-333Arthritis Pain RelieverAcetaminophenOhm Laboratories Inc.ANDACurrent
51660-333Arthritis Pain RelieverAcetaminophenOhm Laboratories Inc.ANDACurrent
51660-333Arthritis Pain RelieverAcetaminophenOhm Laboratories Inc.ANDACurrent
51660-333Arthritis Pain RelieverAcetaminophenOhm Laboratories Inc.ANDACurrent
53329-643AcetaminophenAcetaminophenMedline Industries, Inc.ANDACurrent
53329-643AcetaminophenAcetaminophenMedline Industries, Inc.ANDACurrent
53329-643AcetaminophenAcetaminophenMedline Industries, Inc.ANDACurrent
53329-643AcetaminophenAcetaminophenMedline Industries, Inc.ANDACurrent
53329-643AcetaminophenAcetaminophenMedline Industries, LPANDACurrent
53329-643AcetaminophenAcetaminophenMedline Industries, LPANDACurrent
55315-333AcetaminophenAcetaminophenFred's Inc.ANDACurrent
55315-333AcetaminophenAcetaminophenFred's Inc.ANDACurrent
55319-333AcetaminophenAcetaminophenFamily Dollar Services, Inc.ANDACurrent
55319-333AcetaminophenAcetaminophenFamily Dollar Services, Inc.ANDACurrent
55319-333AcetaminophenAcetaminophenFamily Dollar Services, Inc.ANDACurrent
55319-333AcetaminophenAcetaminophenFamily Dollar Services, Inc.ANDACurrent
55319-333AcetaminophenAcetaminophenFamily Dollar Services, IANDACurrent
55700-679Arthritis Pain RelieverAcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-679Arthritis Pain RelieverAcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-679Arthritis Pain RelieverAcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
59779-336Acetaminophen 8 HourAcetaminophenCVS PharmacyANDACurrent
59779-350AcetaminophenAcetaminophenCVS PharmacyANDACurrent
59779-350AcetaminophenAcetaminophenCVS PharmacyANDACurrent
61919-860ACETAMINOPHENACETAMINOPHENDirectRXANDACurrent
62011-0026AcetaminophenAcetaminophenHealth MartANDACurrent
63868-089AcetaminophenAcetaminophenChain Drug Marketing Association Inc.ANDACurrent
63868-089AcetaminophenAcetaminophenChain Drug Marketing Association Inc.ANDACurrent
63868-091AcetaminophenAcetaminophenChain Drug Marketing Association Inc.ANDACurrent
63868-091AcetaminophenAcetaminophenChain Drug Marketing Association Inc.ANDACurrent
63941-333Acetaminophen - APAP ArthritisAcetaminophenValu Merchandisers CompanyANDACurrent
63941-333Acetaminophen - APAP ArthritisAcetaminophenValu Merchandisers CompanyANDACurrent
63941-336Acetaminophen - APAP 8 HourAcetaminophenValu Merchandisers CompanyANDACurrent
63941-336Acetaminophen - APAP 8 HourAcetaminophenValu Merchandisers CompanyANDACurrent
66336-233Arthritis Pain RelieverAcetaminophenDispensing Solutions, Inc.ANDACurrent
68016-333Premier Value Arthritis Pain RelieverAcetaminophenChain Drug Consortium, LLC.ANDACurrent
68016-333Premier Value Arthritis Pain RelieverAcetaminophenChain Drug Consortium, LLC.ANDACurrent
68016-336Premier Value Arthritis 8 HourAcetaminophenPremier ValueANDACurrent
68016-336Premier Value Arthritis 8 HourAcetaminophenPremier ValueANDACurrent
68071-1552Arthritis Pain RelieverAcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1552Arthritis Pain RelieverAcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1552Arthritis Pain RelieverAcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68084-777Arthritis Pain RelieverAcetaminophenAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43064SUPPL2007-06-11
43063SUPPL2007-06-11
22547SUPPL2007-06-11
22546SUPPL2007-06-11
43062SUPPL2006-04-20
22545ORIG2006-04-20
8876ORIG2002-03-19