Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091496
Company: PERRIGO ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROGLYCERIN NITROGLYCERIN 0.4MG/SPRAY SPRAY, METERED;SUBLINGUAL 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
09/20/2013 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091496Orig1s000ltr.pdf

NITROGLYCERIN

SPRAY, METERED;SUBLINGUAL; 0.4MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN NITROGLYCERIN 0.4MG/SPRAY SPRAY, METERED;SUBLINGUAL Prescription No AB 091496 PERRIGO ISRAEL
NITROLINGUAL PUMPSPRAY NITROGLYCERIN 0.4MG/SPRAY SPRAY, METERED;SUBLINGUAL Prescription Yes AB 018705 POHL BOSKAMP

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