Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208191
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET;SUBLINGUAL Prescription AB No No
NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET;SUBLINGUAL Prescription AB No No
NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET;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
08/26/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208191s001ltr.pdf

NITROGLYCERIN

TABLET;SUBLINGUAL; 0.3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET;SUBLINGUAL Prescription No AB 203693 ACTAVIS LABS FL INC
NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET;SUBLINGUAL Prescription No AB 211604 ALVOGEN MALTA
NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET;SUBLINGUAL Prescription No AB 208191 DR REDDYS LABS INC
NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET;SUBLINGUAL Prescription No AB 206391 GLENMARK PHARMS SA
NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET;SUBLINGUAL Prescription No AB 207745 SIGMAPHARM LABS LLC
NITROSTAT NITROGLYCERIN 0.3MG TABLET;SUBLINGUAL Prescription Yes AB 021134 PFIZER PHARMS

TABLET;SUBLINGUAL; 0.4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET;SUBLINGUAL Prescription No AB 203693 ACTAVIS LABS FL INC
NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET;SUBLINGUAL Prescription No AB 211604 ALVOGEN MALTA
NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET;SUBLINGUAL Prescription No AB 208191 DR REDDYS LABS INC
NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET;SUBLINGUAL Prescription No AB 206391 GLENMARK PHARMS SA
NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET;SUBLINGUAL Prescription No AB 207745 SIGMAPHARM LABS LLC
NITROSTAT NITROGLYCERIN 0.4MG TABLET;SUBLINGUAL Prescription Yes AB 021134 PFIZER PHARMS

TABLET;SUBLINGUAL; 0.6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET;SUBLINGUAL Prescription No AB 203693 ACTAVIS LABS FL INC
NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET;SUBLINGUAL Prescription No AB 211604 ALVOGEN MALTA
NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET;SUBLINGUAL Prescription No AB 208191 DR REDDYS LABS INC
NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET;SUBLINGUAL Prescription No AB 206391 GLENMARK PHARMS SA
NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET;SUBLINGUAL Prescription No AB 207745 SIGMAPHARM LABS LLC
NITROSTAT NITROGLYCERIN 0.6MG TABLET;SUBLINGUAL Prescription Yes AB 021134 PFIZER PHARMS

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