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AmenDrug - Amen The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL
Active Ingredient(s) -
Medroxyprogesterone Acetate
Strength -
10MG
Applicant -
AMARIN PHARMS
New Drug Application (NDA) Number -
083242
Product Number -
001
Therapeutic Equivalence (TE) Code -
Approval Date -
Approved Prior to Jan 1, 1982
Reference Listed Drug (RLD) -
No
Type -
DISCN
Applicant Full Name -
Amarin Pharmaceuticals Inc
Amen
Depo-provera 150mg/ml Injectable; Injection
Depo-provera 400mg/ml Injectable; Injection Medroxyprogesterone Acetate 150mg/ml Injectable; Injection Medroxyprogesterone Acetate 150mg/ml Injectable; Injection Depo-subq Provera 104 104mg/0.65ml Injectable; Subcutaneous Amen 10mg Tablet; Oral Meclofenamate Sodium Eq 50mg Base Capsule; Oral Meclomen Eq 100mg Base Capsule; Oral Meclomen Eq 50mg Base Capsule; Oral Depo-provera 100mg/ml **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Injectable; Injection NewDrugInformation |