Details for New Drug Application (NDA): 203510
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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 203510
Tradename: | PHENYLEPHRINE HYDROCHLORIDE |
Applicant: | Paragon Bioteck |
Ingredient: | phenylephrine hydrochloride |
Patents: | 1 |
Pharmacology for NDA: 203510
Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 203510
Suppliers and Packaging for NDA: 203510
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 203510 | NDA | Paragon BioTeck, Inc. | 42702-102 | 42702-102-10 | 1 BOTTLE, DROPPER in 1 CARTON (42702-102-10) / 10 mL in 1 BOTTLE, DROPPER |
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 203510 | NDA | Paragon BioTeck, Inc. | 42702-102 | 42702-102-15 | 1 BOTTLE, DROPPER in 1 CARTON (42702-102-15) / 15 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 2.5% | ||||
Approval Date: | Mar 21, 2013 | TE: | AT | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 14, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | DILATION OF THE PUPIL |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 10% | ||||
Approval Date: | Mar 21, 2013 | TE: | AT | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 14, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | DILATION OF THE PUPIL |
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