Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091496
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.4MG/SPRAY | SPRAY, METERED;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 |
---|---|---|---|---|---|---|---|
09/20/2013 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091496Orig1s000ltr.pdf |
NITROGLYCERIN
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 |