Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202086
Company: XIROMED
Company: XIROMED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
04/01/2015 | 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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
01/28/2022 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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01/28/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
TABLET;ORAL; 0.035MG;0.4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NEXESTA FE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL | Prescription | No | AB | 207535 | AUROBINDO PHARMA |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL | Prescription | No | AB | 078892 | AMNEAL PHARMS |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL | Prescription | No | AB | 078965 | BARR |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL | Prescription | No | AB | 091332 | LUPIN LTD |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL | Prescription | No | AB | 207066 | NAARI PTE LTD |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL | Prescription | No | AB | 202086 | XIROMED |