Details for New Drug Application (NDA): 080817
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The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE 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 080817
Tradename: | DIPHENHYDRAMINE HYDROCHLORIDE |
Applicant: | West-ward Pharms Int |
Ingredient: | diphenhydramine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 080817
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 080817
Suppliers and Packaging for NDA: 080817
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 080817 | ANDA | Henry Schein, Inc. | 0404-9851 | 0404-9851-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9851-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 080817 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-0376 | 0641-0376-25 | 25 VIAL in 1 PACKAGE (0641-0376-25) / 1 mL in 1 VIAL (0641-0376-21) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
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