Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076979
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCITONIN-SALMON CALCITONIN SALMON 200 IU/SPRAY SPRAY, METERED;NASAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/08/2009 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/076979Orig1s000BioeqR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

07/12/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/18/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

CALCITONIN-SALMON

SPRAY, METERED;NASAL; 200 IU/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCITONIN-SALMON CALCITONIN SALMON 200 IU/SPRAY SPRAY, METERED;NASAL Prescription No AB 076396 APOTEX INC
CALCITONIN-SALMON CALCITONIN SALMON 200 IU/SPRAY SPRAY, METERED;NASAL Prescription No AB 076979 PAR PHARM

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