Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206851
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SIMPESSE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
04/07/2017 | 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 |
---|---|---|---|---|---|
01/20/2023 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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01/20/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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01/20/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
SIMPESSE
TABLET;ORAL; 0.03MG,0.01MG;0.15MG,N/A
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ASHLYNA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 203163 | GLENMARK PHARMS LTD |
DAYSEE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 091467 | LUPIN LTD |
JAIMIESS | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 203770 | XIROMED |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 203872 | AMNEAL PHARMS |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 078834 | DR REDDYS LABS SA |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 200492 | XIROMED |
SEASONIQUE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | Yes | AB | 021840 | TEVA BRANDED PHARM |
SIMPESSE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.01MG;0.15MG,N/A | TABLET;ORAL | Prescription | No | AB | 206851 | AUROBINDO PHARMA |