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Generated: November 21, 2018

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Details for New Drug Application (NDA): 076177

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NDA 076177 describes CAMILA, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the CAMILA profile page.

The generic ingredient in CAMILA 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 076177
Applicant:Mayne Pharma
Formulation / Manufacturing:see details
Pharmacology for NDA: 076177
Ingredient-typeProgesterone Congeners
Medical Subject Heading (MeSH) Categories for 076177
Suppliers and Packaging for NDA: 076177
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAMILA norethindrone TABLET;ORAL-28 076177 ANDA Mayne Pharma Inc. 51862-102 51862-102-06 6 POUCH in 1 CARTON (51862-102-06) > 1 BLISTER PACK in 1 POUCH (51862-102-01) > 28 TABLET in 1 BLISTER PACK
CAMILA norethindrone TABLET;ORAL-28 076177 ANDA Mayne Pharma Inc. 51862-884 51862-884-03 3 BLISTER PACK in 1 CARTON (51862-884-03) > 28 TABLET in 1 BLISTER PACK (51862-884-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Oct 21, 2002TE:AB1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Cantor Fitzgerald
Federal Trade Commission

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