Details for New Drug Application (NDA): 006146
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NDA 006146 describes BENADRYL, which is a drug marketed by Mcneil Cons and is included in three NDAs. Additional details are available on the BENADRYL profile page.
The generic ingredient in BENADRYL is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
The generic ingredient in BENADRYL is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
Summary for 006146
| Tradename: | BENADRYL |
| Applicant: | Mcneil Cons |
| Ingredient: | diphenhydramine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 006146
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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