Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205588
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET;ORAL-28 | 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 |
---|---|---|---|---|---|---|---|
04/26/2016 | 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 |
---|---|---|---|---|---|
08/23/2023 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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08/23/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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08/23/2023 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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04/29/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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10/18/2021 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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07/03/2019 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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04/26/2019 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
NORGESTIMATE AND ETHINYL ESTRADIOL
TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 200494 | GLENMARK PHARMS LTD |
NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 205588 | LUPIN LTD |
NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 200383 | NAARI PTE LTD |
TRI-ESTARYLLA | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 090793 | XIROMED |
TRI-LINYAH | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 090524 | NOVAST LABS LTD |
TRI-MILI | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 205441 | AUROBINDO PHARMA LTD |
TRI-SPRINTEC | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 075808 | BARR |