Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075796
Company: DURAMED PHARMS BARR
Company: DURAMED PHARMS BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AVIANE-21 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-21 | Discontinued | None | No | No |
| AVIANE-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-796_Aviane-21%20and%20Aviane-28_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75796ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-796_Aviane-21.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2010 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/15/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/30/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-796_Aviane-21%20and%20Aviane-28_prntlbl.pdf |
AVIANE-21
There are no Therapeutic Equivalents.
AVIANE-28
TABLET;ORAL-28; 0.02MG;0.1MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AFIRMELLE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 206886 | AUROBINDO PHARMA LTD |
| AVIANE-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 075796 | DURAMED PHARMS BARR |
| FALMINA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 090721 | NOVAST LABS LTD |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 201108 | AMNEAL PHARMS |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 076625 | MAYNE PHARMA |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 200245 | MYLAN LABS LTD |
| VIENVA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 201088 | XIROMED |
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