Details for New Drug Application (NDA): 217032
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NDA 217032 describes PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Alcon, Caplin, Gland, Mankind Pharma, Paragon Bioteck, Accord Hlthcare, Amneal, Aspiro, Avet Lifesciences, Baxter Hlthcare Corp, 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-two NDAs. It is available from thirty-seven suppliers. There are two patents 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 217032
| Tradename: | PHENYLEPHRINE HYDROCHLORIDE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | phenylephrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 217032
| Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 217032
Suppliers and Packaging for NDA: 217032
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 217032 | ANDA | Baxter Healthcare Corporation | 36000-358 | 36000-358-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (36000-358-25) / 1 mL in 1 VIAL, SINGLE-DOSE |
| PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 217032 | ANDA | Baxter Healthcare Corporation | 36000-360 | 36000-360-10 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (36000-360-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/ML (10MG/ML) | ||||
| Approval Date: | Apr 3, 2026 | TE: | AP1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/5ML (10MG/ML) | ||||
| Approval Date: | Apr 3, 2026 | TE: | AP1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/10ML (10MG/ML) | ||||
| Approval Date: | Apr 3, 2026 | TE: | AP1 | RLD: | No | ||||
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