Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205278
Company: XIROMED
Company: XIROMED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | 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 |
---|---|---|---|---|---|---|---|
11/10/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NORETHINDRONE ACETATE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 200275 | AMNEAL PHARMS |
NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075951 | BARR |
NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 091090 | GLENMARK PHARMS LTD |
NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 206490 | NOVAST LABS |
NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 205278 | XIROMED |