Details for New Drug Application (NDA): 207660
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NDA 207660 describes LEVONORGESTREL, which is a drug marketed by Wyeth Pharms Inc, Alvogen, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co Ltd, Lupin Ltd, Naari Pte Ltd, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, Amneal Pharms, Barr, Dr Reddys Labs Sa, and Hetero Labs, and is included in forty-six NDAs. It is available from thirteen suppliers. Additional details are available on the LEVONORGESTREL profile page.
The generic ingredient in LEVONORGESTREL 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.
The generic ingredient in LEVONORGESTREL 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 207660
| Tradename: | LEVONORGESTREL |
| Applicant: | Naari Pte Ltd |
| Ingredient: | levonorgestrel |
| Patents: | 0 |
Pharmacology for NDA: 207660
| Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 207660
Suppliers and Packaging for NDA: 207660
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVONORGESTREL | levonorgestrel | TABLET;ORAL | 207660 | ANDA | Naari Pte Limited | 79929-016 | 79929-016-01 | 1 BLISTER PACK in 1 BOX, UNIT-DOSE (79929-016-01) / 1 TABLET in 1 BLISTER PACK |
| LEVONORGESTREL | levonorgestrel | TABLET;ORAL | 207660 | ANDA | Julie Products Inc | 82791-335 | 82791-335-01 | 1 BLISTER PACK in 1 BOX, UNIT-DOSE (82791-335-01) / 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 2, 2019 | TE: | RLD: | No | |||||
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