Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076783
Company: BARR
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARANELLE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG | 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 |
---|---|---|---|---|---|---|---|
09/29/2004 | 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-16 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
07/06/2020 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
ARANELLE
TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARANELLE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 076783 | BARR |
TRI-NORINYL 28-DAY | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG | TABLET;ORAL-28 | Prescription | Yes | AB | 018977 | DR REDDYS LABS SA |