Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077502
Company: VINTAGE PHARMS LLC
Company: VINTAGE PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYZILRA | 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 |
---|---|---|---|---|---|---|---|
11/23/2011 | 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-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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08/09/2017 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/04/2014 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
MYZILRA
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 |