Details for New Drug Application (NDA): 075406
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NDA 075406 describes OGESTREL 0.5/50-28, which is a drug marketed by Watson Labs and is included in one NDA. Additional details are available on the OGESTREL 0.5/50-28 profile page.
The generic ingredient in OGESTREL 0.5/50-28 is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
The generic ingredient in OGESTREL 0.5/50-28 is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
Summary for 075406
| Tradename: | OGESTREL 0.5/50-28 |
| Applicant: | Watson Labs |
| Ingredient: | ethinyl estradiol; norgestrel |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 15, 1999 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.05MG;0.5MG | ||||
| Approval Date: | Dec 15, 1999 | TE: | RLD: | No | |||||
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