Details for New Drug Application (NDA): 018634
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NDA 018634 describes BETADINE, which is a drug marketed by Alcon Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the BETADINE profile page.
The generic ingredient in BETADINE is povidone-iodine. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the povidone-iodine profile page.
The generic ingredient in BETADINE is povidone-iodine. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the povidone-iodine profile page.
Summary for 018634
| Tradename: | BETADINE |
| Applicant: | Alcon Pharms Ltd |
| Ingredient: | povidone-iodine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018634
Suppliers and Packaging for NDA: 018634
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETADINE | povidone-iodine | SOLUTION/DROPS;OPHTHALMIC | 018634 | NDA | Alcon Laboratories, Inc. | 0065-0411 | 0065-0411-30 | 1 BOTTLE in 1 CARTON (0065-0411-30) / 30 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 5% | ||||
| Approval Date: | Dec 17, 1986 | TE: | RLD: | Yes | |||||
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