Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018705
Company: POHL BOSKAMP
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 |
| 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 |