Bioequivalence

Results: 910



#Item
411Merck / Schering-Plough / Medicine / Gentamicin / Bioequivalence / Betamethasone / Pharmaceutical sciences / Otomax / Otologicals / Pharmacology / Aminoglycoside antibiotics

Date of Approval: November 10, 2011 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA[removed]

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Source URL: www.fda.gov

Language: English
412Pharmaceutical industry / Immunosuppressants / Macrolides / Tacrolimus / Bioequivalence / Generic drug / Dissolution testing / Bioavailability / Pharmacology / Pharmacokinetics / Pharmaceutical sciences

Contains Nonbinding Recommendations

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Source URL: www.fda.gov

Language: English
413Pharmaceuticals policy / Pharmaceutical sciences / Pharmacology / Clinical research / Food law / Prescription Drug User Fee Act / Bioequivalence / Center for Biologics Evaluation and Research / Clinical trial / Food and Drug Administration / Health / Medicine

Guidance for Industry Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees

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Source URL: www.fda.gov

Language: English
414Combination drugs / Merck / Dog health / Otomax / Schering-Plough / Aminoglycoside antibiotics / Clinical research / Bioequivalence / Food and Drug Administration / Pharmacology / Medicine / Pharmaceutical sciences

Date of Approval: March 28, 2003 FREEDOM OF INFORMATION SUMMARY ANADA[removed]Indications for use: GBC Ointmentâ„¢ is used in the treatment of canine acute and chronic

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Source URL: www.fda.gov

Language: English
415Bioequivalence / Dissolution testing / Abbreviated New Drug Application / Chemistry / Medicine / Carprofen / Dog health / Organochlorides

Date of Approval: April 27, 2005 FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION (ANADA) ANADA[removed]

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Source URL: www.fda.gov

Language: English
416Medicine / Penicillin / Bioequivalence / Erysipelothrix rhusiopathiae / Food and Drug Administration / Benzylpenicillin / Pharmacology / Beta-lactam antibiotics / Pharmaceutical sciences

Date of Approval: January 29, 2004 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION (ANADA) ANADA[removed]

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Source URL: www.fda.gov

Language: English
417Organofluorides / Dosage forms / Clinical research / Bioequivalence / Pharmacokinetics / Triamcinolone / Topical / Cream / Acetonide / Pharmacology / Medicine / Pharmaceutical sciences

Date of Approval: February 4, 2000 FREEDOM OF INFORMATION SUMMARY 1. General Information:

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Source URL: www.fda.gov

Language: English
418Pharmacokinetics / Organochlorides / Lactams / Aripiprazole / Neurophysiology / Bioequivalence / Cmax / Norfloxacin / Antipsychotic / Chemistry / Organic chemistry / Piperazines

Microsoft Word[removed]corr2.doc

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Source URL: www.fda.gov

Language: English
419Pharmaceutical sciences / Beekeeping / Oxytetracycline / Bioequivalence / Tetracycline / Food and Drug Administration / Medicine / Tetracycline antibiotics / Pharmacology

Oxytetracycline hydrochloride

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Source URL: www.fda.gov

Language: English
420Pharmacokinetics / Omeprazole / Abbreviated New Drug Application / Chemistry / Organic chemistry / Pharmacology / Bioequivalence / Clinical research

Date of Approval: July 1, 2008 FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION NADA[removed]

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Source URL: www.fda.gov

Language: English
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