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GovernmentDocs 5/4/2008 | 0 (0) | 24 | 0 | 0 | English
NDA 21-087/S-042 NDA 21-246/S-030 January 17, 2008 Page 3TAMIFLU?? (oseltamivir phosphate) CAPSULES AND FOR ORAL SUSPENSION Rx only DESCRIPTION TAMIFLU (oseltamivir phosphate) is available as ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 52 | 0 | 0 | English
Electronic Document RoomConformance Review Checklist For NDAsAppl_Type Appl_NoDrug_NameSponsor_ApplicantU.S. Department of Health and Human Services Food and Dr... ... more>>
FDADocs 5/9/2008 | 0 (0) | 12 | 0 | 0 | English
NDA 21-014/SLR-012 NDA 21-285/SLR-007 Page 3T2005Trileptal ??(oxcarbazepine) Tablets Oral Suspension Rx only Prescribing InformationDESCRIPTIONTrileptal?? (oxcarbazepine) is an ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 81 | 0 | 0 | English
Guidance for IndustryChanges to an Approved NDA or ANDAU.S. Department of Health and Human...Guidance for IndustryChanges to an Approved NDA or ANDAAdditional copies are available ... more>>
FDADocs 5/5/2008 | 0 (0) | 23 | 0 | 0 | English
Sample LetterDear: The purpose of this letter is to inform you that the Food and Drug Administration (FDA) has decided to require that all levothyroxine sodium products approve... ... more>>
FDADocs 5/9/2008 | 0 (0) | 12 | 0 | 0 | English
FDADocs 5/12/2008 | 0 (0) | 15 | 0 | 0 | English
LisaB1982 5/5/2008 | 0 (0) | 346 | 5 | 0 | German
Non-disclosure Agreement (NDA)Zwischen ___________________________________ ___________________________________ ___________________________________ und ... more>>
fathatdesign 11/6/2007 | 5.9 (8) | 6359 | 1329 | 4 | English
A free non-disclosure agreement you can use for your business. ... more>>
Jason 12/9/2007 | 9 (1) | 1663 | 94 | 0 | English
??? 1 ??? COMPANY NAME [ADDRESS] [ADDRESS] _______________, 200_ CONFIDENTIAL Company /Person Name. [ADDRESS] [ADDRESS] Tel: Email: Attention: [NAME] Dear [NAME]: Confidentiality a... ... more>>
Semaj1212 4/9/2008 | 0 (0) | 71 | 0 | 0 | English
GovernmentDocs 5/5/2008 | 0 (0) | 13 | 0 | 0 | English
NDA 50-710/S-023 NDA 50-711/S-019 NDA 50-784/S-007Page 3ZITHROMAX??(azithromycin tablets) and (azithromycin for oral suspension)To reduce the development of drug-resistant bacteria and ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 10 | 0 | 0 | English
NDA 20-080/S-005Glaxo Wellcome Inc. Attention: Mr. James E. Murray Five Moore Drive PO BOX 13398 Research Triangle Park, NC 27709 Dear Mr. Murray: Ple&e refer to your March 9, 1993 supplemental ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 17 | 0 | 0 | English
NDA 21-153/S-027 NDA 21-689/S-008 Page 28NEXIUM?? I.V.(esomeprazole sodium) for Injection Rx only DESCRIPTION The active ingredient in NEXIUM?? I.V. (esomeprazole sodium) for Injection is (S ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 15 | 0 | 0 | English
NDA 20-905/S-006 NDA 20-905/S-007 Page 4 Rev. XXX ARAVA??? Tablets (leflunomide) 10 mg, 20 mg, 100 mg Rx only CONTRAINDICATIONS AND WARNINGS PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT ... more>>
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