Details for New Drug Application (NDA): 202635
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NDA 202635 describes OPCICON ONE-STEP, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from six suppliers. Additional details are available on the OPCICON ONE-STEP profile page.
The generic ingredient in OPCICON ONE-STEP is levonorgestrel. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
The generic ingredient in OPCICON ONE-STEP is levonorgestrel. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 202635
| Tradename: | OPCICON ONE-STEP |
| Applicant: | Sun Pharm |
| Ingredient: | levonorgestrel |
| Patents: | 0 |
Pharmacology for NDA: 202635
| Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 202635
Suppliers and Packaging for NDA: 202635
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OPCICON ONE-STEP | levonorgestrel | TABLET;ORAL | 202635 | ANDA | Rugby Laboratories | 0536-1142 | 0536-1142-63 | 1 BLISTER PACK in 1 CARTON (0536-1142-63) / 1 TABLET in 1 BLISTER PACK |
| OPCICON ONE-STEP | levonorgestrel | TABLET;ORAL | 202635 | ANDA | Ohm Laboratories Inc. | 51660-723 | 51660-723-11 | 1 BLISTER PACK in 1 CARTON (51660-723-11) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Sep 11, 2014 | TE: | RLD: | No | |||||
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