Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205131
Company: XIROMED
Company: XIROMED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,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 |
---|---|---|---|---|---|---|---|
12/14/2017 | 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 |
---|---|---|---|---|---|
03/30/2023 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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03/30/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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08/30/2018 | SUPPL-1 | Labeling-Proprietary Name Change |
Label is not available on this site. |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
TABLET;ORAL; 0.02MG,0.1MG;0.01MG,N/A
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 091674 | LUPIN LTD |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 200493 | XIROMED |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 205131 | XIROMED |
LO SIMPESSE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 206852 | AUROBINDO PHARMA |
LOSEASONIQUE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET;ORAL | Prescription | No | AB | 022262 | TEVA BRANDED PHARM |