Details for New Drug Application (NDA): 205723
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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 205723
Tradename: | DIPHENHYDRAMINE HYDROCHLORIDE |
Applicant: | Micro Labs |
Ingredient: | diphenhydramine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 205723
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 205723
Suppliers and Packaging for NDA: 205723
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 205723 | ANDA | Micro Labs Limited | 42571-169 | 42571-169-55 | 10 AMPULE in 1 CARTON (42571-169-55) / 1 mL in 1 AMPULE (42571-169-54) |
DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 205723 | ANDA | Micro Labs Limited | 42571-337 | 42571-337-87 | 25 VIAL in 1 CARTON (42571-337-87) / 1 mL in 1 VIAL (42571-337-95) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
Approval Date: | Aug 22, 2018 | TE: | AP | RLD: | No |
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