Details for New Drug Application (NDA): 073594
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The generic ingredient in LEVORA 0.15/30-28 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 073594
Tradename: | LEVORA 0.15/30-28 |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 073594
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVORA 0.15/30-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 073594 | ANDA | Mayne Pharma Inc. | 51862-097 | 51862-097-06 | 6 BLISTER PACK in 1 CARTON (51862-097-06) / 1 KIT in 1 BLISTER PACK (51862-097-01) |
LEVORA 0.15/30-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 073594 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1565 | 53002-1565-1 | 1 BLISTER PACK in 1 PACKAGE (53002-1565-1) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.15MG | ||||
Approval Date: | Dec 13, 1993 | TE: | AB | RLD: | No |
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