Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018705
Company: POHL BOSKAMP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROLINGUAL NITROGLYCERIN 0.4MG/SPRAY AEROSOL;SUBLINGUAL Discontinued None No No
NITROLINGUAL PUMPSPRAY NITROGLYCERIN 0.4MG/SPRAY SPRAY, METERED;SUBLINGUAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/31/1985 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/30/2018 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018705s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018705Orig1s025ltr.pdf
04/21/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/23/2015 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018705s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018705Orig1s019ltr.pdf
10/01/2008 SUPPL-17 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018705s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018705s017ltr.pdf
09/28/2006 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018705s016LTR.pdf
02/13/2006 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018705s015ltr.pdf
09/02/2004 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18705s013ltr.pdf
11/05/2002 SUPPL-12 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18705scp012ltr.pdf
11/04/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/04/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/13/1999 SUPPL-8 Labeling

Label is not available on this site.

04/24/1998 SUPPL-7 Labeling

Label is not available on this site.

01/10/1997 SUPPL-6 Efficacy-Accelerated Approval Confirmatory Study

Label is not available on this site.

01/11/1995 SUPPL-5 Labeling

Label is not available on this site.

03/02/1990 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1989 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/02/1988 SUPPL-2 Labeling

Label is not available on this site.

04/23/1986 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/30/2018 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018705s025lbl.pdf
01/23/2015 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018705s019lbl.pdf
10/01/2008 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018705s017lbl.pdf
10/01/2008 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018705s017lbl.pdf

NITROLINGUAL

There are no Therapeutic Equivalents.

NITROLINGUAL PUMPSPRAY

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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