Details for New Drug Application (NDA): 075883
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NDA 075883 describes AMMONIUM LACTATE, which is a drug marketed by Padagis Israel, Sun Pharma Canada, and Watson Labs Inc, and is included in six NDAs. It is available from five 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the ammonium lactate profile page.
Summary for 075883
| Tradename: | AMMONIUM LACTATE |
| Applicant: | Sun Pharma Canada |
| Ingredient: | ammonium lactate |
| Patents: | 0 |
Pharmacology for NDA: 075883
| Mechanism of Action | Acidifying Activity |
Suppliers and Packaging for NDA: 075883
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMMONIUM LACTATE | ammonium lactate | CREAM;TOPICAL | 075883 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1301 | 51672-1301-0 | 385 g in 1 BOTTLE, PLASTIC (51672-1301-0) |
| AMMONIUM LACTATE | ammonium lactate | CREAM;TOPICAL | 075883 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1301 | 51672-1301-2 | 1 TUBE in 1 CARTON (51672-1301-2) / 140 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | EQ 12% BASE | ||||
| Approval Date: | Apr 10, 2003 | TE: | AB | RLD: | No | ||||
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