Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078376
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GILDAGIA | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | 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 |
---|---|---|---|---|---|---|---|
11/06/2012 | 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-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
08/09/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
GILDAGIA
TABLET;ORAL-28; 0.035MG;0.4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BALZIVA-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 076238 | BARR |
BRIELLYN | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 090538 | GLENMARK PHARMS LTD |
GILDAGIA | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 078376 | ENDO OPERATIONS |
NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 078323 | WATSON LABS |
PHILITH | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 090947 | NOVAST LABS LTD |
VYFEMLA | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 201886 | LUPIN LTD |