Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204299
Company: NOVEL LABS INC
Company: NOVEL LABS INC
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/03/2015 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/29/2019 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/29/2019 | SUPPL-1 | Labeling-Package Insert |
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 | 204299 | NOVEL LABS INC |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 1.75MG | TABLET;SUBLINGUAL | Prescription | No | AB | 204229 | PAR PHARM 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 | 204299 | NOVEL LABS INC |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 3.5MG | TABLET;SUBLINGUAL | Prescription | No | AB | 204229 | PAR PHARM INC |