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Mesalamine
Mesalamine - 43386-510-87 - (Mesalamine)
Drug Information of Mesalamine
| Product NDC: | 43386-510 |
| Proprietary Name: | Mesalamine |
| Non Proprietary Name: | Mesalamine |
| Active Ingredient(s): | 4 g/60mL & nbsp; Mesalamine |
| Administration Route(s): | RECTAL |
| Dosage Form(s): | ENEMA |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Mesalamine
| Product NDC: | 43386-510 |
| Labeler Name: | GAVIS Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA019618 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20091216 |
Package Information of Mesalamine
| Package NDC: | 43386-510-87 |
| Package Description: | 7 BOTTLE, UNIT-DOSE in 1 CARTON (43386-510-87) > 60 mL in 1 BOTTLE, UNIT-DOSE (43386-510-81) |
NDC Information of Mesalamine
| NDC Code | 43386-510-87 |
| Proprietary Name | Mesalamine |
| Package Description | 7 BOTTLE, UNIT-DOSE in 1 CARTON (43386-510-87) > 60 mL in 1 BOTTLE, UNIT-DOSE (43386-510-81) |
| Product NDC | 43386-510 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Mesalamine |
| Dosage Form Name | ENEMA |
| Route Name | RECTAL |
| Start Marketing Date | 20091216 |
| Marketing Category Name | ANDA |
| Labeler Name | GAVIS Pharmaceuticals, LLC |
| Substance Name | MESALAMINE |
| Strength Number | 4 |
| Strength Unit | g/60mL |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |
