Drugs@FDA: FDA-Approved Drugs
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 | 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 | UPJOHN |
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 | 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 | UPJOHN |
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 | 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 | UPJOHN |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English