Drugs@FDA: FDA-Approved Drugs
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 | |
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-Container/Carton Labels, Labeling-Package Insert |
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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018705s017lbl.pdf | |
10/01/2008 | SUPPL-17 | Labeling-Package Insert | 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 | PADAGIS ISRAEL |
NITROLINGUAL PUMPSPRAY | NITROGLYCERIN | 0.4MG/SPRAY | SPRAY, METERED;SUBLINGUAL | Prescription | Yes | AB | 018705 | POHL BOSKAMP |