Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075478
Company: BARR
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORTREL 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-21 | Prescription | None | No | No |
NORTREL 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 |
---|---|---|---|---|---|---|---|
08/30/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75478TA.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-22 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/06/2020 | SUPPL-18 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
08/26/2016 | SUPPL-17 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
01/20/2015 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
12/31/2014 | SUPPL-13 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
04/20/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
NORTREL 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 |