Details for New Drug Application (NDA): 076216
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NDA 076216 describes AMMONIUM LACTATE, which is a drug marketed by Padagis Israel, Taro, and Watson Labs Inc, and is included in six NDAs. It is available from six suppliers. Additional details are available on the AMMONIUM LACTATE profile page.
The generic ingredient in AMMONIUM LACTATE is ammonium lactate. There are forty drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ammonium lactate profile page.
The generic ingredient in AMMONIUM LACTATE is ammonium lactate. There are forty drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ammonium lactate profile page.
Summary for 076216
| Tradename: | AMMONIUM LACTATE |
| Applicant: | Taro |
| Ingredient: | ammonium lactate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076216
| Mechanism of Action | Acidifying Activity |
Suppliers and Packaging for NDA: 076216
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMMONIUM LACTATE | ammonium lactate | LOTION;TOPICAL | 076216 | ANDA | A-S Medication Solutions | 50090-6587 | 50090-6587-0 | 225 g in 1 BOTTLE, PLASTIC (50090-6587-0) |
| AMMONIUM LACTATE | ammonium lactate | LOTION;TOPICAL | 076216 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1300 | 51672-1300-5 | 225 g in 1 BOTTLE, PLASTIC (51672-1300-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | EQ 12% BASE | ||||
| Approval Date: | May 28, 2004 | TE: | AB | RLD: | No | ||||
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