Details for New Drug Application (NDA): 202508
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NDA 202508 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 fifteen 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 202508
| Tradename: | LEVONORGESTREL |
| Applicant: | Novel Labs Inc |
| Ingredient: | levonorgestrel |
| Patents: | 0 |
Pharmacology for NDA: 202508
| Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 202508
Suppliers and Packaging for NDA: 202508
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVONORGESTREL | levonorgestrel | TABLET;ORAL | 202508 | ANDA | Novel Laboratories, Inc. | 40032-622 | 40032-622-30 | 1 TABLET in 1 CARTON (40032-622-30) |
| LEVONORGESTREL | levonorgestrel | TABLET;ORAL | 202508 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-622 | 43386-622-30 | 1 TABLET in 1 CARTON (43386-622-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Feb 22, 2013 | TE: | RLD: | No | |||||
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