FDA.reportPublic FDA data

Application 091071

Type
ANDA
Sponsor
ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL600MG;60MGNoNo
002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1.2GM;120MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091071-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2015-05-27
A091071-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2015-05-27

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A091071-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2015-05-27f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A091071-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2015-05-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091071-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2015-05-27e64feba35796…
2022-09-29 23:25 UTC2022-09A091071-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2015-05-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091071-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2015-05-27cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091071-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2015-05-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091071-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2015-05-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091071-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2015-05-27a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCc857bcd9-6696-40d5-93c0-65097598cd4b2022-04-08WarningsName fallback
brand name: Guaifenesin and Pseudoephedrine Hydrochloride
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCd139fd8d-66fd-4484-8e78-ed90c505d9992022-02-08WarningsName fallback
brand name: Guaifenesin and Pseudoephedrine Hydrochloride
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN COMPANY310d14be-e7ea-44b8-8b04-cffa39440d502018-10-27WarningsName fallback
brand name: Guaifenesin and Pseudoephedrine Hydrochloride

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 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-2002Mucus DGuaifenesin, pseudoephedrine hydrochlorideL. Perrigo CompanyANDACurrent
0113-2002Mucus DGuaifenesin, pseudoephedrine hydrochlorideL. Perrigo CompanyANDACurrent
0363-0144Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideWalgreen CompanyANDACurrent
0363-0144Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideWalgreen CompanyANDACurrent
0536-1205rugby mucus relief dGuaifenesin, pseudoephedrine hydrochlorideRugby LaboratoriesANDACurrent
11822-0144mucus relief dGuaifenesin, pseudoephedrine hydrochlorideRite Aid CorporationANDACurrent
11822-0144mucus relief dGuaifenesin, pseudoephedrine hydrochlorideRite Aid CorporationANDACurrent
30142-144Mucus DGuaifenesin, pseudoephedrine hydrochlorideKroger CompanyANDACurrent
30142-144Mucus DGuaifenesin, pseudoephedrine hydrochlorideKroger CompanyANDACurrent
30142-144Mucus DGuaifenesin, pseudoephedrine hydrochlorideKroger CompanyANDACurrent
30142-144Mucus DGuaifenesin, pseudoephedrine hydrochlorideKroger CompanyANDACurrent
36800-144TopCare Mucus DGuaifenesin, pseudoephedrine hydrochlorideTopco Associates LLCANDACurrent
37808-446Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideH E BANDACurrent
37808-446Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideH E BANDACurrent
37808-777mucus relief dGuaifenesin, pseudoephedrine hydrochlorideH E BANDACurrent
37808-777mucus relief dGuaifenesin, pseudoephedrine hydrochlorideH E BANDACurrent
41250-144Mucus DGuaifenesin, pseudoephedrine hydrochlorideMeijer Distribution IncANDACurrent
45802-230Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochloridePerrigo New York IncANDACurrent
45802-230Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochloridePerrigo New York IncANDACurrent
45802-230Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochloridePadagis Israel Pharmaceuticals LtdANDACurrent
46122-239Good Neighbor Pharmacy Mucus DGuaifenesin, pseudoephedrine hydrochlorideAmerisource BergenANDACurrent
49035-729equate mucus dguaifenesin, pseudoephedrine hydrochlorideWal-Mart Stores IncANDACurrent
49035-792equate mucus dguaifenesin, pseudoephedrine hydrochlorideWal-Mart Stores IncANDACurrent
49348-113Sunmark mucus relief dGuaifenesin, pseudoephedrine hydrochlorideMcKessonANDACurrent
49348-113Sunmark mucus relief dGuaifenesin, pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
49348-113Sunmark mucus relief dGuaifenesin, pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
55316-144healthy accents mucus relief DGuaifenesin, pseudoephedrine hydrochlorideDZA Brands LLCANDACurrent
56062-144Mucus D ERGuaifenesin, pseudoephedrine hydrochloridePublix Super Markets IncANDACurrent
56062-144Mucus D ERGuaifenesin, pseudoephedrine hydrochloridePublix Super Markets IncANDACurrent
59779-825Mucus DGuaifenesin, pseudoephedrine hydrochlorideCVS PharmacyANDACurrent
59779-825Mucus DGuaifenesin, pseudoephedrine hydrochlorideCVS PharmacyANDACurrent
62011-0259Health Mart mucus relief dGuaifenesin, pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
62011-0259Health Mart mucus relief dGuaifenesin, pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
62011-0259Health Mart mucus relief dGuaifenesin, pseudoephedrine hydrochlorideMcKessonANDACurrent
63187-960Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochlorideProficient Rx LPANDACurrent
63187-960Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochlorideProficient Rx LPANDACurrent
69256-144Harris Teeter Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideHarris Teeter, LLCANDACurrent
69256-144Harris Teeter Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideHarris Teeter, LLCANDACurrent
70000-0004leader mucus relief dGuaifenesin, pseudoephedrine hydrochlorideCardinal HealthANDACurrent
70000-0004leader mucus relief dGuaifenesin, pseudoephedrine hydrochlorideCardinal Health 110, LLC. dba LeaderANDACurrent
70518-0011Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31514ORIG2015-06-02