Drugs@FDA: FDA-Approved Drugs
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORTREL 1/35-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | 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 |
---|---|---|---|---|---|---|---|
02/28/1992 | 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-33 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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02/10/2022 | SUPPL-28 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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02/10/2022 | SUPPL-27 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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02/10/2022 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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02/27/2013 | SUPPL-23 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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12/04/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/04/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/11/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/07/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/13/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/21/1999 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/07/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
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03/07/2001 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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03/07/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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03/07/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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03/07/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NORTREL 1/35-28
TABLET;ORAL-28; 0.035MG;1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALYACEN 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 091634 | GLENMARK PHARMS LTD |
DASETTA 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 090948 | NOVAST LABS LTD |
NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 206864 | NAARI PTE LTD |
NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 070687 | WATSON LABS TEVA |
NORTREL 1/35-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 072696 | BARR |
NYLIA 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 207056 | AUROBINDO PHARMA |