Details for New Drug Application (NDA): 087513
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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 087513
Tradename: | DIPHENHYDRAMINE HYDROCHLORIDE |
Applicant: | Pharm Assoc |
Ingredient: | diphenhydramine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 087513
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 087513
Suppliers and Packaging for NDA: 087513
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | ELIXIR;ORAL | 087513 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0489 | 0121-0489-00 | 10 TRAY in 1 CASE (0121-0489-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0489-05) |
DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | ELIXIR;ORAL | 087513 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0978 | 0121-0978-00 | 10 TRAY in 1 CASE (0121-0978-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0978-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | ELIXIR;ORAL | Strength | 12.5MG/5ML | ||||
Approval Date: | Feb 10, 1982 | TE: | RLD: | Yes |
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