← FDA Drug Approvals (Drugs@FDA)
VIORELE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2012-04-02
Drug application
- FDA Application #
ANDA091346- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- VIORELE
- Generic name
- DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Active ingredients
- DESOGESTREL; ETHINYL ESTRADIOL
- Dosage form
- TABLET
- Route
- ORAL-28
- Marketing status
- Prescription
- Sponsor
- GLENMARK PHARMS LTD
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- First approval
- 2012-04-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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