Dockets

Recently active federal rulemakings, soonest-closing first.

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Submission of 510k's for Solid Stat X-Ray Imaging DevicesFDANonrulemaking
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Transmittal of Advertisements/Promotional Labelings DrugsFDANonrulemaking
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CGMP in Mfg. Processing, Packing or Holding of Drugs; RevisionFDANonrulemaking
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Refrain from Granting AVITA an "A" Rating, (Orange Book)FDANonrulemaking
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Issue A Final Approval for Its ANDA 74-488 Effective 7/10/97FDANonrulemaking
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ANDA for Mefenamic Acid Tablets, 250mgFDANonrulemaking
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Require that Warning Labels About Risks of Salmonella EnteritidisFDANonrulemaking
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PSA/Standardization of Certain Grass Pollen ExtractsFDANonrulemaking
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Incubation Cycle Antimicrobialsusceptibility Devices/ClassIificationFDANonrulemaking
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ANDA Suitability for Famotidine 10mg Effervescent TabletsFDANonrulemaking
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Label Foods & Beverages Containing Greater Than 5mg CaffeineFDANonrulemaking
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Prohibit Approval of Generic Versions of ToradolFDANonrulemaking
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Clarify Specific Data for Approval of Abbreviation New Drug ApplicationFDANonrulemaking
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Listed Drug Capsules Change in Dosage Form & StrengthsFDANonrulemaking
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Approved Drug Product List with Therapeutic Equivalence Evaluation be amended by designating second reference listed drug for albuterol sulfate extended release tablets, eg 4 mgFDANonrulemaking
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ANDA for Sublingual Tablet Formulation of Albuterol SulfateFDANonrulemaking
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ANDA Suitability for A Diltiazem Hydrochloride Extended ReleaseFDANonrulemaking
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Provide Warning Labels for Prozac to ConsumersFDANonrulemaking
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Amend Strength in Fludeoxyglucose InjectionFDANonrulemaking
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Definitions & Standards of Identity for Bakery ProductsFDANonrulemaking
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Endolymphatic Shunt Tube with Valve Change in ClassificationFDANonrulemaking
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Bedford Laboratories Request to ANDA Filed for 30mg/mL Ketorolac Tromethamine InjectionFDANonrulemaking
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Amend the Advisory Committee RegulationsFDANonrulemaking
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Drug Acetaminophen Tend to Deplete Glutathione for HIV-InfectionFDANonrulemaking
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Caloric Value Not More Than Two Per Gram for Soluble FiberFDANonrulemaking
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Permit Filing of an ANDA Pseudoephedrine HydrochlorideFDANonrulemaking
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ANDA Suitability for Lyophilized Leucovorin Calcium InjectionFDANonrulemaking
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CP Regarding Soluble Fiber from Whole Oats & Coronary DiseaseFDANonrulemaking
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Harmonize the Agency's Acceptable Document Delivery Methods.FDANonrulemaking
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ANDA for Silver Sulfadiazine 1% CreamFDANonrulemaking
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Hair Defects in Imported Canned MushroomsFDANonrulemaking
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Dietary Supplements, Courtesy Letters (Letters of Objection)FDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light Show for LPR 1000 Laser ProjectorFDANonrulemaking
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Investigating out of Specification(OOS)Test Results fr PharmFDANonrulemaking
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Microbial Effects of Antimicrobial New Animal Drugs/Human SafetyFDANonrulemaking
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Withdrawn From Sale of Tylosterone TabletsFDANonrulemaking
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Combination oxycodone hyrochloride/acetaminophen tablet-CLOSEDFDANonrulemaking
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Advisory Opinion Oxine(stabilized Chlorine Dioxide) in Sweetwater SystemsFDANonrulemaking
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Transmission of Zoonoses by Blood & Blood ProductsFDANonrulemaking
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New Use Food Contact Substance Notification Systems-ToxicolologyFDANonrulemaking
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Sampling & Microbial Testing of Spent Irrigation WaterFDANonrulemaking
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Health Claims for Conventional Foods & Dietary SupplementsFDANonrulemaking
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Impurities: Residual Solvents in New Veterinary MedicinalFDANonrulemaking
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Patent Term Extension Application for Isolex 300 and ISOLEX 300i, U.S. Patent No. 4,714,680FDANonrulemaking
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Patent Term Extension for Uvadex, U.S. Patent No. 4,999,375FDANonrulemaking
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Tridecanol Phosphite Butylidenebis[2-(1,-dimethylethy)-5-metFDANonrulemaking
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Benzenepropanoic Acid, 3-5-bis(1,1-dimethylethy)-4-hydroxy-FDANonrulemaking
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National Fisheries Institute and the Louisiana Department of AgricultureFDANonrulemaking
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