Details for New Drug Application (NDA): 080027
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NDA 080027 describes ALCAINE, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the ALCAINE profile page.
The generic ingredient in ALCAINE is proparacaine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.
The generic ingredient in ALCAINE is proparacaine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.
Summary for 080027
| Tradename: | ALCAINE |
| Applicant: | Alcon Labs Inc |
| Ingredient: | proparacaine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 080027
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 080027
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALCAINE | proparacaine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 080027 | ANDA | Alcon Laboratories, Inc. | 0998-0016 | 0998-0016-15 | 1 BOTTLE in 1 CARTON (0998-0016-15) / 15 mL in 1 BOTTLE |
| ALCAINE | proparacaine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 080027 | ANDA | Sandoz Inc. | 61314-016 | 61314-016-01 | 1 BOTTLE in 1 CARTON (61314-016-01) / 15 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
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