Details for New Drug Application (NDA): 019618
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The generic ingredient in SFROWASA is mesalamine. There are twenty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 019618
Tradename: | SFROWASA |
Applicant: | Mylan Speciality Lp |
Ingredient: | mesalamine |
Patents: | 1 |
Suppliers and Packaging for NDA: 019618
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROWASA | mesalamine | ENEMA;RECTAL | 019618 | NDA | Meda Pharmaceuticals Inc. | 0037-0022 | 0037-0022-07 | 7 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60) |
ROWASA | mesalamine | ENEMA;RECTAL | 019618 | NDA | Meda Pharmaceuticals Inc. | 0037-0022 | 0037-0022-28 | 28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | ENEMA;RECTAL | Strength | 4GM/60ML | ||||
Approval Date: | Dec 24, 1987 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | ENEMA;RECTAL | Strength | 4GM/60ML | ||||
Approval Date: | Jun 20, 2008 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 24, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 019618
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618-001 | Dec 24, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618-001 | Dec 24, 1987 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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