Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207054
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NYLIA 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | 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 |
---|---|---|---|---|---|---|---|
10/21/2016 | ORIG-1 | Approval | STANDARD |
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-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
06/11/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
NYLIA 7/7/7
TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALYACEN 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 091636 | GLENMARK PHARMS LTD |
DASETTA 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 090946 | NOVAST LABS LTD |
NORTREL 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 075478 | BARR |
NYLIA 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 207054 | AUROBINDO PHARMA |