Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202349
Company: WATSON LABS INC
Company: WATSON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTRADIOL VALERATE AND DIENOGEST | DIENOGEST; ESTRADIOL VALERATE | N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 05/09/2017 | ORIG-1 | Tentative Approval |
Label is not available on this site. |
ESTRADIOL VALERATE AND DIENOGEST
TABLET;ORAL; N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL VALERATE AND DIENOGEST | DIENOGEST; ESTRADIOL VALERATE | N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A | TABLET;ORAL | Prescription | No | AB | 202349 | WATSON LABS INC |
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