| Specifications | Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use FDA 356H PSC Publishing Services |
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| Specifications | Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use FDA 356H PSC Publishing Services |
| Business section |
| Specifications | Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use FDA 356H PSC Publishing Services |
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| Content | DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, OR AN ANTIBIOTIC DRUG FOR HUMAN USE (Title 21, Code of Federal Regulations, Parts 314 & 601) Form Approved: OMB No. 0910-0338 Expiration Date: December 31, 2013 See OMB Statement on page 2. FOR FDA USE ONLY APPLICATION NUMBER AUTHORIZED U.S. AGENT NAME & ADDRESS (Number, Street, City, State, ZIP Code, Telephone & FAX Numbers), IF APPLICABLE ANNUAL REPORT LABELING SUPPLEMENT OTHER PRODUCT DESCRIPTION NEW DRUG OR ANTIBIOTIC APPLICATION NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMBER (If previously issued) ESTABLISHED NAME (e.g., proper name, USP/USAN name) PROPRIETARY NAME (trade name) IF ANY CHEMICAL/BIOCHEMICAL/BLOOD PRODUCT NAME (If any) CODE NAME (If any) DOSAGE FORM STRENGTHS ROUTE OF ADMINISTRATION (PROPOSED) INDICATION(S) FOR USE: APPLICATION INFORMATION APPLICATION TYPE (check one) NEW DRUG APPLICATION (CDA, 21 CFR 314.50) ABBREVIATED NEW DRUG APPLICATION (ANDA, 21 CFR 314.94) BIOLOGICS LICENSE APPLICATION (BLA, 21 CFR Part 601) IF AN NDA, IDENTIFY THE APPROPRIATE TYPE 505 (b)(1) 505 (b)(2) IF AN ANDA, OR 505(b)(2), IDENTIFY THE REFERENCE LISTED DRUG PRODUCT THAT IS THE BASIS FOR THE SUBMISSION Name of Drug Holder of Approved Application TYPE OF SUBMISSION (check one) ORIGINAL APPLICATION AMENDMENT TO A PENDING APPLICATION RESUBMISSION PRESUBMISSION ESTABLISHMENT DESCRIPTION SUPPLEMENT EFFICACY SUPPLEMENT CHEMISTRY, MANUFACTURING, AND CONTROLS SUPPLEMENT IF A SUBMISSION OF PARTIAL APPLICATION, PROVIDE LETTER DATE OF AGREEMENT TO PARTIAL SUBMISSION: IF A SUPPLEMENT, IDENTIFY THE APPROPRIATE CATEGORY CBE CBE-30 Prior Approval (PA) REASON FOR SUBMISSION PROPOSED MARKETING STATUS (check one) PRESCRIPTION PRODUCT (Rx) OVER- THE-COUNTER PRODUCT (OTC) NUMBER OF VOLUMES SUBMITTED THIS APPLICATION IS PAPER PAPER AND ELE CTRONIC ELECTRONIC MEDIA ESTABLISHMENT INFORMATION (Full establishment information should be provided in the body of the application.) Provide locations of all manufacturing, packaging and control sites for drug substance and drug product (continuation sheets may be used if necessary). Include name, address, contact, telephone number, registration number (CFN), DMF number, and manufacturing steps and/or type of testing (e.g., final dosage form, stability testing) conducted at the site. Please indicate whether the site is ready for inspection or, if not, when it will be ready. CROSS REFERENCES (List related License Applications, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, and DMFs referenced in the current application.) FORM FDA 356h (12/11) PAGE 1 OF 4 APPLICANT INFORMATION NAME OF APPLICANT DATE OF SUBMISSION TELEPHONE NO. (Include Area Code) FACSIMILE (FAX) Number (Include Area Code) APPLICANT ADDRESS (Number, Street, City, State, Country, ZIP Code or Mail Code, and U.S. License Number if previously issued): Next Page Export DataImport Data Reset Form |
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| Following Datasheets | UCM082359_1 (2 pages) UCM082725-1_1 (1 pages) UCM082725_1 (1 pages) UCM083533_1 (2 pages) UCM083558_1 (2 pages) UCM083570_1 (1 pages) ucm085819_1 (3 pages) UCM086233_1 (46 pages) ucm089021_1 (4 pages) ucm089809_1 (6 pages) |
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