Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076334
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREVIFEM | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;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 |
---|---|---|---|---|---|---|---|
01/09/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076334_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-24 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
02/03/2022 | SUPPL-23 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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02/24/2016 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
04/30/2014 | SUPPL-20 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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02/24/2016 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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01/03/2013 | SUPPL-17 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
PREVIFEM
TABLET;ORAL-28; 0.035MG;0.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTARYLLA | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 090794 | XIROMED |
MILI | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 205449 | AUROBINDO PHARMA LTD |
MONO-LINYAH | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 090523 | NOVAST LABS LTD |
NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 200538 | GLENMARK PHARMS LTD |
NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 205630 | LUPIN LTD |
NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 200384 | NAARI PTE LTD |
PREVIFEM | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 076334 | ENDO OPERATIONS |
SPRINTEC | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 075804 | BARR |