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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 075288


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NDA 075288 describes LOW-OGESTREL-28, which is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. It is available from two suppliers. Additional details are available on the LOW-OGESTREL-28 profile page.

The generic ingredient in LOW-OGESTREL-28 is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
Summary for 075288
Tradename:LOW-OGESTREL-28
Applicant:Dr Reddys Labs Sa
Ingredient:ethinyl estradiol; norgestrel
Patents:0
Suppliers and Packaging for NDA: 075288
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOW-OGESTREL-21 ethinyl estradiol; norgestrel TABLET;ORAL-21 075288 ANDA Mayne Pharma Inc. 51862-564 51862-564-06 6 BLISTER PACK in 1 CARTON (51862-564-06) / 1 KIT in 1 BLISTER PACK (51862-564-01)
LOW-OGESTREL-21 ethinyl estradiol; norgestrel TABLET;ORAL-21 075288 ANDA RPK Pharmaceuticals, Inc. 53002-1637 53002-1637-1 1 BLISTER PACK in 1 PACKAGE (53002-1637-1) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.03MG;0.3MG
Approval Date:Jul 28, 1999TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;0.3MG
Approval Date:Jul 28, 1999TE:ABRLD:No

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