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AZELEX
AZELEX - 54868-4442-0 - (azelaic acid)
Drug Information of AZELEX
| Product NDC: | 54868-4442 |
| Proprietary Name: | AZELEX |
| Non Proprietary Name: | azelaic acid |
| Active Ingredient(s): | .2 g/g & nbsp; azelaic acid |
| Administration Route(s): | CUTANEOUS |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of AZELEX
| Product NDC: | 54868-4442 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020428 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20070531 |
Package Information of AZELEX
| Package NDC: | 54868-4442-0 |
| Package Description: | 1 TUBE in 1 CARTON (54868-4442-0) > 30 g in 1 TUBE |
NDC Information of AZELEX
| NDC Code | 54868-4442-0 |
| Proprietary Name | AZELEX |
| Package Description | 1 TUBE in 1 CARTON (54868-4442-0) > 30 g in 1 TUBE |
| Product NDC | 54868-4442 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | azelaic acid |
| Dosage Form Name | CREAM |
| Route Name | CUTANEOUS |
| Start Marketing Date | 20070531 |
| Marketing Category Name | NDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | AZELAIC ACID |
| Strength Number | .2 |
| Strength Unit | g/g |
| Pharmaceutical Classes | Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] |
