Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Request for Nominations--Letters Posted so Far for Public Viewing

Nomination from the Prescription Center re Ammonium Tetrathiomolybdate

• See Attached

• Public Submission
• Posted:
  03/07/2014
• ID:
  FDA-2013-N-1525-0002

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Nomination from Fagron, Inc., re Carbonyl Iron and Feosol Carbonyl Iron MAE3

• Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Dear Sir or Madam, We hereby nominate Carbonyl Iron for...

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0004

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Nomination from Freedom Pharmaceuticals re Acetyl-D-Glucosamine

• Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Dear Sir or Madam, We hereby nominate Acetyl-D Glucosamine...

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0010

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Nomination from Freedom Pharmaceuticals re Aloe Vera

• Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Dear Sir or Madam, We hereby nominate Aloe Vera 200:1...

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0011

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Nomination from Fagron Inc., Chlorella and Chlorella MAE3

• Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Dear Sir or Madam, We hereby nominate Chlorella for...

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0005

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from Freedom Pharmaceuticals Inc

• See Attached

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0007

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Nomination from Freedom Pharmaceuticals re Beta Glucan

• Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Dear Sir or Madam, We hereby nominate Beta Glucan (1,3/1,4...

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0014

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from B&B Pharmaceuticals, Inc.

• See Attached

• Public Submission
• Posted:
  03/10/2014
• ID:
  FDA-2013-N-1525-0003

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Nomination from Freedom Pharmaceuticals re Ashwagandha Extract

• Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Dear Sir or Madam, We hereby nominate Ashwagandha Extract 2...

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0012

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Cover Letter from Freedom Pharmaceuticals Inc for Inclusion on Bulk Drug Substances re Nomination from Freedom Pharmaceuticals Inc re 7 Keto Dehydroepiandrosterone DHEA

• Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Dear Sir or Madam, We hereby nominate 7-Keto...

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0006

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Nomination from Freedom Pharmaceuticals re Astragalus Extract 10 1

• Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Dear Sir or Madam, We hereby nominate Astragalus Extract 10...

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0013

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment and Nomination from National Home Infusion Association re L Glutamic Acid and L Taurine

• See Attached

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0008

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1525

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Cover Letter from Fagron Inc for Inclusion on Bulk Drug Substances re Nomination from Fagron Inc

• Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Dear Sir or Madam, We hereby nominate the drugs listed below...

• Public Submission
• Posted:
  03/20/2014
• ID:
  FDA-2013-N-1525-0009