Details for New Drug Application (NDA): 216830
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NDA 216830 describes PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. It is available from one supplier. Additional details are available on the PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE profile page.
The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is phenylephrine hydrochloride. There are twenty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride profile page.
The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is phenylephrine hydrochloride. There are twenty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride profile page.
Summary for 216830
| Tradename: | PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | phenylephrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216830
| Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 216830
Suppliers and Packaging for NDA: 216830
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 216830 | NDA | Dr. Reddy's Laboratories Inc. | 43598-182 | 43598-182-05 | 5 BAG in 1 CARTON (43598-182-05) / 250 mL in 1 BAG (43598-182-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/250ML (0.08MG/ML) | ||||
| Approval Date: | May 30, 2025 | TE: | RLD: | Yes | |||||
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