Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206391
Company: GLENMARK PHARMS SA
Company: GLENMARK PHARMS SA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | AB | No | No |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | AB | No | No |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;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 |
---|---|---|---|---|---|---|---|
09/19/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206391Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/27/2018 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/27/2018 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
NITROGLYCERIN
TABLET;SUBLINGUAL; 0.3MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217879 | AUROBINDO PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 208191 | DR REDDYS |
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 206391 | GLENMARK PHARMS SA |
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217970 | MANKIND PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 211604 | NATCO |
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 209779 | RUBICON |
NITROSTAT | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | Yes | AB | 021134 | VIATRIS |
TABLET;SUBLINGUAL; 0.4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217879 | AUROBINDO PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 208191 | DR REDDYS |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 206391 | GLENMARK PHARMS SA |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217970 | MANKIND PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 211604 | NATCO |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 209779 | RUBICON |
NITROSTAT | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | Yes | AB | 021134 | VIATRIS |
TABLET;SUBLINGUAL; 0.6MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217879 | AUROBINDO PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 208191 | DR REDDYS |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 206391 | GLENMARK PHARMS SA |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217970 | MANKIND PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 211604 | NATCO |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 209779 | RUBICON |
NITROSTAT | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | Yes | AB | 021134 | VIATRIS |