Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075809
Company: DURAMED PHARMS BARR
Company: DURAMED PHARMS BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENPRESSE-21 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET;ORAL-21 | Discontinued | None | No | No |
ENPRESSE-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | 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 |
---|---|---|---|---|---|---|---|
07/16/2001 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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01/28/2022 | SUPPL-27 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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01/28/2022 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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08/09/2017 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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06/19/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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05/21/2002 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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03/12/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
ENPRESSE-21
There are no Therapeutic Equivalents.
ENPRESSE-28
TABLET;ORAL-28; 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENPRESSE-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET;ORAL-28 | Prescription | No | AB | 075809 | DURAMED PHARMS BARR |
LEVONEST | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET;ORAL-28 | Prescription | No | AB | 090719 | NOVAST LABS LTD |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET;ORAL-28 | Prescription | No | AB | 200248 | LUPIN LTD |
MYZILRA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET;ORAL-28 | Prescription | No | AB | 077502 | VINTAGE PHARMS LLC |
TRIVORA-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET;ORAL-28 | Prescription | No | AB | 074538 | DR REDDYS LABS SA |