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11 NDA 74187, Sodium Tablets USP O. O25mg,O. O5mg,O. O75mg, O.OMFG, 0. Leg, O.l22mg, O.l25mg, O.l5mg, O.l75mg, 0.2 mg and0.3 MGG Milan Pharmaceuticals Approval Date: June $2002 0361. AND 76-187
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What is 11 nda 74187 sodium?
11 NDA 74187 sodium is a specific drug that falls under the New Drug Application (NDA) number 74187 approved by the regulatory authorities. It is a sodium variant of the drug with specific properties or characteristics.
Who is required to file 11 nda 74187 sodium?
The pharmaceutical company or manufacturer that holds the rights to 11 NDA 74187 sodium is required to file the application for its approval.
How to fill out 11 nda 74187 sodium?
To fill out the New Drug Application (NDA) for 11 NDA 74187 sodium, the pharmaceutical company needs to provide comprehensive information about the drug, including its formulation, manufacturing process, safety data, clinical trial results, proposed labeling, and any other required documentation as per regulatory guidelines. This information is submitted to the appropriate regulatory authorities for review and approval.
What is the purpose of 11 nda 74187 sodium?
The purpose of 11 NDA 74187 sodium is to seek regulatory approval for the drug. This approval enables the pharmaceutical company to legally market and sell the drug for the specified indications or uses.
What information must be reported on 11 nda 74187 sodium?
The New Drug Application (NDA) for 11 NDA 74187 sodium requires comprehensive information, including the drug's composition, manufacturing process, safety profile, clinical trial data, proposed labeling, indications, contraindications, side effects, dosage instructions, and any other relevant information as per regulatory requirements.
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