Details for New Drug Application (NDA): 202380
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The generic ingredient in LEVONORGESTREL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 202380
Tradename: | LEVONORGESTREL |
Applicant: | Naari Pte Ltd |
Ingredient: | levonorgestrel |
Patents: | 0 |
Pharmacology for NDA: 202380
Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 202380
Suppliers and Packaging for NDA: 202380
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVONORGESTREL | levonorgestrel | TABLET;ORAL | 202380 | ANDA | Strides Pharma Inc | 59556-282 | 59556-282-01 | 1 BLISTER PACK in 1 CARTON (59556-282-01) / 1 TABLET in 1 BLISTER PACK |
LEVONORGESTREL | levonorgestrel | TABLET;ORAL | 202380 | ANDA | Strides Pharma Inc | 59556-286 | 59556-286-01 | 1 BLISTER PACK in 1 CARTON (59556-286-01) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
Approval Date: | May 29, 2015 | TE: | RLD: | No |
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