Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078324
Company: BRECKENRIDGE PHARM
Company: BRECKENRIDGE PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | AB | No | No |
ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | 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 |
---|---|---|---|---|---|---|---|
04/17/2008 | 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 |
---|---|---|---|---|---|
06/09/2011 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
ESTRADIOL AND NORETHINDRONE ACETATE
TABLET;ORAL; 1MG;0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | Yes | AB | 020907 | AMNEAL |
ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 079193 | BARR |
ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 078324 | BRECKENRIDGE PHARM |
ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 210233 | NAARI PTE LTD |
ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 210612 | NOVAST LABS |
ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 207261 | XIROMED |
TABLET;ORAL; 0.5MG;0.1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | No | AB | 078324 | BRECKENRIDGE PHARM |
ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | No | AB | 210612 | NOVAST LABS |
ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | No | AB | 207261 | XIROMED |