Declare That the Drug Product, Mefenamic Acid Capsules USP, 500mg, is Suitable for Consideration in an Abbreviated New Drug Application (ANDA)

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Docket ID : FDA-2012-P-1058
Agency : Food and Drug Administration (FDA)
Parent Agency : Department of Health and Human Services (HHS)
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Related RINs: None
Related Dockets: None
Docket Item Code: P
Type: Nonrulemaking
Center: CDER
Legacy ID: 2012-8526
Short Title: Declare That the Drug Product, Mefenamic Acid Capsules USP, 500mg, is Suitable for Consideration in an ANDA
Keyword(s): cder, 2012-8526, mefenamic acid, capsules, 500 mg, anda, rld, ponstel, 250 mg, shionogi inc, nda 15-034, oral, prea, dysmenorrhea, dosage strength, open
Docket Status: OPEN
 
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Comments Received *
* The total reflects comments received from Regulations.gov and other means as of 11:59 PM yesterday. All comments received may not be posted at this time including bulk submissions; therefore, the total comments received and posted may differ.