Details for New Drug Application (NDA): 202635
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The generic ingredient in OPCICON ONE-STEP is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-four 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 |
Formulation / Manufacturing: | see details |
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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