Details for New Drug Application (NDA): 216859
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The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 216859
Tradename: | PHENYLEPHRINE HYDROCHLORIDE |
Applicant: | Mankind Pharma |
Ingredient: | phenylephrine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216859
Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 216859
Suppliers and Packaging for NDA: 216859
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 216859 | ANDA | Lifestar Pharma LLC | 70756-629 | 70756-629-25 | 1 BOTTLE, DROPPER in 1 CARTON (70756-629-25) / 2 mL in 1 BOTTLE, DROPPER |
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 216859 | ANDA | Lifestar Pharma LLC | 70756-649 | 70756-649-35 | 1 BOTTLE, DROPPER in 1 CARTON (70756-649-35) / 15 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 2.5% | ||||
Approval Date: | Sep 29, 2022 | TE: | AT | RLD: | No |
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