Details for New Drug Application (NDA): 020286
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The generic ingredient in MONOPRIL-HCT is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
Summary for 020286
| Tradename: | MONOPRIL-HCT |
| Applicant: | Bristol Myers Squibb |
| Ingredient: | fosinopril sodium; hydrochlorothiazide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 30, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 30, 1994 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020286
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | MONOPRIL-HCT | fosinopril sodium; hydrochlorothiazide | TABLET;ORAL | 020286-002 | Nov 30, 1994 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bristol Myers Squibb | MONOPRIL-HCT | fosinopril sodium; hydrochlorothiazide | TABLET;ORAL | 020286-001 | Nov 30, 1994 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bristol Myers Squibb | MONOPRIL-HCT | fosinopril sodium; hydrochlorothiazide | TABLET;ORAL | 020286-001 | Nov 30, 1994 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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