Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204503
Company: DR REDDYS
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 1.75MG | TABLET;SUBLINGUAL | Prescription | AB | No | No |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 3.5MG | 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 |
---|---|---|---|---|---|---|---|
11/18/2016 | ORIG-1 | Approval |
Label is not available on this site. |
ZOLPIDEM TARTRATE
TABLET;SUBLINGUAL; 1.75MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 1.75MG | TABLET;SUBLINGUAL | Prescription | No | AB | 204503 | DR REDDYS |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 1.75MG | TABLET;SUBLINGUAL | Prescription | No | AB | 204229 | ENDO OPERATIONS |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 1.75MG | TABLET;SUBLINGUAL | Prescription | No | AB | 204299 | NOVEL LABS INC |
TABLET;SUBLINGUAL; 3.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 3.5MG | TABLET;SUBLINGUAL | Prescription | No | AB | 204503 | DR REDDYS |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 3.5MG | TABLET;SUBLINGUAL | Prescription | No | AB | 204229 | ENDO OPERATIONS |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 3.5MG | TABLET;SUBLINGUAL | Prescription | No | AB | 204299 | NOVEL LABS INC |