Details for New Drug Application (NDA): 016911
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NDA 016911 describes DELALUTIN, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. Additional details are available on the DELALUTIN profile page.
The generic ingredient in DELALUTIN is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
The generic ingredient in DELALUTIN is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
Summary for 016911
| Tradename: | DELALUTIN |
| Applicant: | Bristol Myers Squibb |
| Ingredient: | hydroxyprogesterone caproate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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