Details for New Drug Application (NDA): 208953
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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 208953
Tradename: | MESALAMINE |
Applicant: | Zydus Pharms |
Ingredient: | mesalamine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208953
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MESALAMINE | mesalamine | SUPPOSITORY;RECTAL | 208953 | ANDA | Northstar Rx LLC. | 16714-245 | 16714-245-30 | 5 BLISTER PACK in 1 POUCH (16714-245-30) / 6 SUPPOSITORY in 1 BLISTER PACK (16714-245-01) |
MESALAMINE | mesalamine | SUPPOSITORY;RECTAL | 208953 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1302 | 70710-1302-7 | 5 BLISTER PACK in 1 POUCH (70710-1302-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1302-6) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 1GM | ||||
Approval Date: | Feb 12, 2020 | TE: | AB | RLD: | No |
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