Details for New Drug Application (NDA): 203826
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NDA 203826 describes PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Alcon, Caplin, Gland, Mankind Pharma, Paragon Bioteck, Accord Hlthcare, Amneal, Aspiro, Avet Lifesciences, Be Pharms, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hikma, Meitheal, Milla Pharms, Ph Health, Sagent Pharms Inc, Sandoz, Somerset Theraps Llc, Genus, and Dr Reddys Labs Sa, and is included in thirty-one NDAs. It is available from thirty-six suppliers. There is one patent protecting this drug. Additional details are available on the PHENYLEPHRINE HYDROCHLORIDE profile page.
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.
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 203826
| Tradename: | PHENYLEPHRINE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | phenylephrine hydrochloride |
| Patents: | 3 |
Pharmacology for NDA: 203826
| Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 203826
Suppliers and Packaging for NDA: 203826
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMMPHENTIV | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 203826 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6142 | 0641-6142-25 | 25 VIAL in 1 CARTON (0641-6142-25) / 1 mL in 1 VIAL (0641-6142-01) |
| IMMPHENTIV | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 203826 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6188 | 0641-6188-10 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0641-6188-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6188-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/ML (10MG/ML) | ||||
| Approval Date: | Dec 20, 2012 | TE: | AP2 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/5ML (10MG/ML) | ||||
| Approval Date: | Jun 19, 2019 | TE: | AP2 | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/10ML (10MG/ML) | ||||
| Approval Date: | Jun 19, 2019 | TE: | AP2 | RLD: | Yes | ||||
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