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Generated: November 21, 2018

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Details for New Drug Application (NDA): 076225

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NDA 076225 describes ERRIN, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the ERRIN profile page.

The generic ingredient in ERRIN is norethindrone. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
Summary for 076225
Tradename:ERRIN
Applicant:Mayne Pharma
Ingredient:norethindrone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076225
Ingredient-typeProgesterone Congeners
Medical Subject Heading (MeSH) Categories for 076225
Suppliers and Packaging for NDA: 076225
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERRIN norethindrone TABLET;ORAL-28 076225 ANDA Teva Pharmaceuticals USA, Inc. 0555-0344 0555-0344-58 6 BLISTER PACK in 1 BOX (0555-0344-58) > 28 TABLET in 1 BLISTER PACK (0555-0344-79)
ERRIN norethindrone TABLET;ORAL-28 076225 ANDA Mayne Pharma Inc. 51862-100 51862-100-06 6 BLISTER PACK in 1 CARTON (51862-100-06) > 28 TABLET in 1 BLISTER PACK (51862-100-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Oct 21, 2002TE:AB2RLD:No

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