Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206886
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AFIRMELLE | 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 |
---|---|---|---|---|---|---|---|
11/14/2016 | 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-2 | Labeling-Package Insert |
Label is not available on this site. |
||
08/09/2017 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
AFIRMELLE
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 |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 207065 | NAARI PTE LTD |
VIENVA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 201088 | XIROMED |
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