http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
FDA Drug Approvals List- February 1999
Applicant: CONNETICS CORP Active Ingredient(s): BETAMETHASONE VALERATE OTC/RX Status: RX Indication(s):For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp Original Application #: 020969 Approval Date: 25-FEB-99 Trade Name: UVADEX Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: THERAKOS...
20969LTR.PDF
UVADEX ® (Methoxsalen) STERILE SOLUTION, 20 mcg/ mL Uvadex O (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T- cell lymphoma and who have special training and experience in the UVAR ® Photopheresis System The chemical name of methoxsalen is 9- methoxy-...
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20969LTR.PDF
NDA 20- 969 THERAKOS, Inc Schwartz: Please refer to your new drug application (NDA) dated February 20, 1998, received February 25, 1998, and submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for UVADEX ® (methoxsalen) Sterile Solution, 20 mcg/ mL We acknowledge receipt of your submissions dated March 19 and 26; April 16, 17, and 29;...
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Premarket Approval Decisions September 1999
FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH PMA Final Decisions Rendered for September 1999 Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities P990004 9/30/99 SURGIFOAM Absorbable Gelatin Sponge, U.S.P P820003/S074 9/1/99 Model 5388 External Pulse...
author: OSM/DID
Premarket Approval Decisions for March 2000
FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH PMA Final Decisions Rendered for March 2000 Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities HAZELWOOD, MO 63042 APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC NALIDIXIC ACID AT CONCETRATIONS OF 8, 16, AND 32UG...
author: OSM/DID
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