Details for New Drug Application (NDA): 083213
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NDA 083213 describes PRAMOSONE, which is a drug marketed by Sebela Ireland Ltd and Ferndale Labs and is included in five NDAs. It is available from three suppliers. Additional details are available on the PRAMOSONE profile page.
The generic ingredient in PRAMOSONE is hydrocortisone acetate; pramoxine hydrochloride. There are sixty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.
The generic ingredient in PRAMOSONE is hydrocortisone acetate; pramoxine hydrochloride. There are sixty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.
Summary for 083213
| Tradename: | PRAMOSONE |
| Applicant: | Ferndale Labs |
| Ingredient: | hydrocortisone acetate; pramoxine hydrochloride |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | LOTION;TOPICAL | Strength | 0.5%;1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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