Details for New Drug Application (NDA): 212909
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NDA 212909 describes BIORPHEN, 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 BIORPHEN profile page.
The generic ingredient in BIORPHEN 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 BIORPHEN 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 212909
| Tradename: | BIORPHEN |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | phenylephrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212909
| Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 212909
Suppliers and Packaging for NDA: 212909
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BIORPHEN | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 212909 | NDA | Dr. Reddy's Laboratories Inc. | 43598-172 | 43598-172-15 | 10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05) |
| BIORPHEN | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 212909 | NDA | Dr. Reddy's Laboratories Inc. | 43598-172 | 43598-172-25 | 5 mL in 1 VIAL (43598-172-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.5MG/5ML (0.1MG/ML) | ||||
| Approval Date: | Oct 21, 2019 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/ML (10MG/ML) | ||||
| Approval Date: | Mar 11, 2021 | TE: | RLD: | Yes | |||||
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