Details for New Drug Application (NDA): 007984
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The generic ingredient in AMBODRYL is bromodiphenhydramine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the bromodiphenhydramine hydrochloride profile page.
Summary for 007984
| Tradename: | AMBODRYL |
| Applicant: | Parke Davis |
| Ingredient: | bromodiphenhydramine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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