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ASACOL HD
ASACOL HD - 0430-0783-95 - (mesalamine)
Drug Information of ASACOL HD
| Product NDC: | 0430-0783 |
| Proprietary Name: | ASACOL HD |
| Non Proprietary Name: | mesalamine |
| Active Ingredient(s): | 800 mg/1 & nbsp; mesalamine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, DELAYED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of ASACOL HD
| Product NDC: | 0430-0783 |
| Labeler Name: | Warner Chilcott (US), LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021830 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20080528 |
Package Information of ASACOL HD
| Package NDC: | 0430-0783-95 |
| Package Description: | 24 CARTON in 1 CASE (0430-0783-95) > 1 BOTTLE in 1 CARTON > 12 TABLET, DELAYED RELEASE in 1 BOTTLE |
NDC Information of ASACOL HD
| NDC Code | 0430-0783-95 |
| Proprietary Name | ASACOL HD |
| Package Description | 24 CARTON in 1 CASE (0430-0783-95) > 1 BOTTLE in 1 CARTON > 12 TABLET, DELAYED RELEASE in 1 BOTTLE |
| Product NDC | 0430-0783 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | mesalamine |
| Dosage Form Name | TABLET, DELAYED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20080528 |
| Marketing Category Name | NDA |
| Labeler Name | Warner Chilcott (US), LLC |
| Substance Name | MESALAMINE |
| Strength Number | 800 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |
