Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 200961
Company: NOVAST LABS
Company: NOVAST LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | AB2 | 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 |
|---|---|---|---|---|---|---|---|
| 09/13/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/29/2014 | SUPPL-1 | Labeling-Proprietary Name Change |
Label is not available on this site. |
NORETHINDRONE
TABLET;ORAL-28; 0.35MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ERRIN | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 076225 | MAYNE PHARMA |
| JENCYCLA | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 091323 | LUPIN LTD |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 091209 | GLENMARK GENERICS |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 200980 | MYLAN LABS LTD |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 200961 | NOVAST LABS |
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