Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 207745
Company: SIGMAPHARM LABS LLC
Company: SIGMAPHARM LABS LLC
| 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 |
|---|---|---|---|---|---|---|---|
| 05/07/2018 | ORIG-1 | Approval | STANDARD |
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 | 203693 | ACTAVIS LABS FL INC |
| NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 211604 | ALVOGEN |
| 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 | 207745 | SIGMAPHARM LABS LLC |
| NITROSTAT | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | Yes | AB | 021134 | PFIZER PHARMS |
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 | 203693 | ACTAVIS LABS FL INC |
| NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 211604 | ALVOGEN |
| 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 | 207745 | SIGMAPHARM LABS LLC |
| NITROSTAT | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | Yes | AB | 021134 | PFIZER PHARMS |
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 | 203693 | ACTAVIS LABS FL INC |
| NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 211604 | ALVOGEN |
| 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 | 207745 | SIGMAPHARM LABS LLC |
| NITROSTAT | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | Yes | AB | 021134 | PFIZER PHARMS |
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