Details for New Drug Application (NDA): 213377
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The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 213377
Tradename: | MESALAMINE |
Applicant: | Annora Pharma |
Ingredient: | mesalamine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213377
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MESALAMINE | mesalamine | SUPPOSITORY;RECTAL | 213377 | ANDA | Camber Pharmaceuticals, Inc. | 31722-005 | 31722-005-30 | 5 PACKAGE in 1 CARTON (31722-005-30) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32) |
MESALAMINE | mesalamine | SUPPOSITORY;RECTAL | 213377 | ANDA | Camber Pharmaceuticals, Inc. | 31722-005 | 31722-005-31 | 7 PACKAGE in 1 CARTON (31722-005-31) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 1GM | ||||
Approval Date: | Mar 19, 2020 | TE: | AB | RLD: | No |
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