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APRISO
APRISO - 65649-103-02 - (mesalamine)
Drug Information of APRISO
| Product NDC: | 65649-103 |
| Proprietary Name: | APRISO |
| Non Proprietary Name: | mesalamine |
| Active Ingredient(s): | 375 mg/1 & nbsp; mesalamine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of APRISO
| Product NDC: | 65649-103 |
| Labeler Name: | Salix Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022301 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20081031 |
Package Information of APRISO
| Package NDC: | 65649-103-02 |
| Package Description: | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65649-103-02) |
NDC Information of APRISO
| NDC Code | 65649-103-02 |
| Proprietary Name | APRISO |
| Package Description | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65649-103-02) |
| Product NDC | 65649-103 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | mesalamine |
| Dosage Form Name | CAPSULE, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20081031 |
| Marketing Category Name | NDA |
| Labeler Name | Salix Pharmaceuticals, Inc. |
| Substance Name | MESALAMINE |
| Strength Number | 375 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |
