Details for New Drug Application (NDA): 040607
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NDA 040607 describes ACETIC ACID, which is a drug marketed by Chartwell Rx, Kv Pharm, Rising, Saptalis Pharms, Taro, B Braun, Baxter Hlthcare, Icu Medical Inc, and Bausch And Lomb, and is included in ten NDAs. It is available from four suppliers. Additional details are available on the ACETIC ACID profile page.
The generic ingredient in ACETIC ACID is acetic acid, glacial; hydrocortisone. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.
The generic ingredient in ACETIC ACID is acetic acid, glacial; hydrocortisone. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.
Summary for 040607
| Tradename: | ACETIC ACID |
| Applicant: | Saptalis Pharms |
| Ingredient: | acetic acid, glacial |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 040607
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETIC ACID | acetic acid, glacial | SOLUTION/DROPS;OTIC | 040607 | ANDA | A-S Medication Solutions | 50090-6527 | 50090-6527-0 | 1 BOTTLE in 1 CARTON (50090-6527-0) / 15 mL in 1 BOTTLE |
| ACETIC ACID | acetic acid, glacial | SOLUTION/DROPS;OTIC | 040607 | ANDA | TruPharma, LLC | 52817-816 | 52817-816-15 | 1 BOTTLE in 1 CARTON (52817-816-15) / 15 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | 2% | ||||
| Approval Date: | Feb 24, 2005 | TE: | AT | RLD: | No | ||||
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