Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200490
Company: XIROMED
Company: XIROMED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | 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 |
---|---|---|---|---|---|---|---|
04/21/2015 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/18/2023 | SUPPL-13 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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11/18/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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02/28/2019 | SUPPL-4 | Labeling-Proprietary Name Change |
Label is not available on this site. |
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02/28/2019 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
LEVONORGESTREL AND ETHINYL ESTRADIOL
TABLET;ORAL; 0.03MG;0.15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ICLEVIA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 206850 | AUROBINDO PHARMA LTD |
INTROVALE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 079064 | XIROMED |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 203871 | AMNEAL PHARMS |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 203164 | GLENMARK PHARMS LTD |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 091440 | LUPIN LTD |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 200490 | XIROMED |
QUASENSE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 077101 | WATSON LABS |
SEASONALE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | Yes | AB | 021544 | TEVA BRANDED PHARM |
SETLAKIN | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL | Prescription | No | AB | 090716 | NOVAST LABS |