Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075808
Company: BARR
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRI-SPRINTEC | 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 |
---|---|---|---|---|---|---|---|
12/29/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075808_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/27/2023 | SUPPL-45 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/27/2023 | SUPPL-43 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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04/29/2022 | SUPPL-40 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
01/27/2022 | SUPPL-34 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
04/13/2016 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
04/13/2016 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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02/21/2013 | SUPPL-29 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
TRI-SPRINTEC
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 |