Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091204
Company: NOVAST LABS LTD
Company: NOVAST LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
WERA | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/27/2012 | 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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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02/28/2022 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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02/28/2022 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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09/29/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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09/29/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
WERA
TABLET;ORAL-28; 0.035MG;0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYONANZ | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 207055 | AUROBINDO PHARMA |
NORTREL 0.5/35-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 072695 | BARR |
WERA | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 091204 | NOVAST LABS LTD |