Details for New Drug Application (NDA): 218129
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NDA 218129 describes PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Alcon, Caplin, Gland Pharma Ltd, Mankind Pharma, Paragon Bioteck, Accord Hlthcare, Amneal, Aspiro, Avet Lifesciences, Be Pharms, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hikma, Meitheal, Provepharm Sas, Sagent Pharms Inc, Sandoz, Somerset Theraps Llc, and Genus, and is included in thirty NDAs. It is available from thirty-three 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 218129
| Tradename: | PHENYLEPHRINE HYDROCHLORIDE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | phenylephrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218129
| Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 218129
Suppliers and Packaging for NDA: 218129
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 218129 | ANDA | Gland Pharma Limited | 68083-593 | 68083-593-01 | 1 BOTTLE, DROPPER in 1 CARTON (68083-593-01) / 2 mL in 1 BOTTLE, DROPPER |
| PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 218129 | ANDA | Gland Pharma Limited | 68083-594 | 68083-594-01 | 1 BOTTLE, DROPPER in 1 CARTON (68083-594-01) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 2.5% | ||||
| Approval Date: | Dec 18, 2024 | TE: | AT | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 10% | ||||
| Approval Date: | Dec 18, 2024 | TE: | AT | RLD: | No | ||||
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