Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217334
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Prescription | AB | No | No |
ESTRADIOL | ESTRADIOL | 2MG | 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 |
---|---|---|---|---|---|---|---|
09/06/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ESTRADIOL
TABLET;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 040197 | BARR LABS INC |
ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 040275 | EPIC PHARMA LLC |
ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 217334 | NOVITIUM PHARMA |
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Prescription | No | AB | 040197 | BARR LABS INC |
ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Prescription | No | AB | 040275 | EPIC PHARMA LLC |
ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Prescription | No | AB | 217334 | NOVITIUM PHARMA |
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 2MG | TABLET;ORAL | Prescription | No | AB | 040197 | BARR LABS INC |
ESTRADIOL | ESTRADIOL | 2MG | TABLET;ORAL | Prescription | No | AB | 040275 | EPIC PHARMA LLC |
ESTRADIOL | ESTRADIOL | 2MG | TABLET;ORAL | Prescription | No | AB | 217334 | NOVITIUM PHARMA |