Jun 21st, 2015
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Adelphi University
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PIROXICAM GELNoDescriptionSection No1. Drug Authority Application form 2. Name and Address of Applicant *& Manufacturer 3. Name of the Product 4 Free Sale certificate I5. CertificateII6. Certificate of the composition of the product giving in detail the chemistry of the active ingredient / ingredient of the product. ill7. Detailed specification and standards laid down by the manufacturer for each product together with its method of analysis in details. IV8. A certificate of sterility and absence of pyrogen wherever it is applicable V9. Six samples of the product applied for registration in their original pack. VI10. Certificate of Analysis VII11. Reference Sample VIII12. Bioavailability studies I IX13. Safety and Tolerance studies & Test X14. Detailed Reports covering a) Pharmacological b) Toxicological c) Clinical aspects XI15. Storage Date XII16. Authenticated price list XIII17. Name of the competitive drugs manufactured by other firms XIV18. Other countries where the product is Registered XV19. Date of introduction of the product to the market in the country of origin. XIV COMPOSITION OF THE PRODUCT PRODUCT : ROXICAM GEL Batch No. :01 Batch Size : 300.0 kgs NO INGREDIENTS SPEC. LABEL CLAIM W/W OVER AGES QTY IN KGS 1 Piroxicam IP 0.50 % 5.0 % 1.575 2 Carbomer 934 USP 0.90 % 2.700 3 Glycerin IP 10.00 % 30.000 4 Propylene glycol IP 20.00 % 60.00

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