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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018705
Company: POHL BOSKAMP

Products on NDA 018705

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018705

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
09/02/2016	SUPPL-21	Labeling-Container/Carton Labels		Label is not available on this site.
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.

Labels for NDA 018705

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

Therapeutic Equivalents for NDA 018705

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	PADAGIS ISRAEL
NITROLINGUAL PUMPSPRAY	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED;SUBLINGUAL	Prescription	Yes	AB	018705	POHL BOSKAMP

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