Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076455
Company: DURAMED PHARMS BARR
Company: DURAMED PHARMS BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESOGESTREL; ETHINYL | DESOGESTREL; ETHINYL ESTRADIOL | 0.125MG/0.025MG | Tablet; Oral | Prescription | None | No | No |
DESOGESTREL; ETHINYL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG/0.025MG | Tablet; Oral | Prescription | None | No | No |
VELIVET | DESOGESTREL; ETHINYL ESTRADIOL | 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG | 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 |
---|---|---|---|---|---|---|---|
02/24/2004 | 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 |
---|---|---|---|---|---|
07/14/2011 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
DESOGESTREL; ETHINYL
There are no Therapeutic Equivalents.
VELIVET
TABLET;ORAL-28; 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLESSA | DESOGESTREL; ETHINYL ESTRADIOL | 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG | TABLET;ORAL-28 | Prescription | Yes | AB | 021090 | ASPEN GLOBAL INC |
VELIVET | DESOGESTREL; ETHINYL ESTRADIOL | 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG | TABLET;ORAL-28 | Prescription | No | AB | 076455 | DURAMED PHARMS BARR |