Details for New Drug Application (NDA): 021998
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NDA 021998 describes PLAN B ONE-STEP, which is a drug marketed by Fdn Consumer and is included in one NDA. It is available from two suppliers. Additional details are available on the PLAN B ONE-STEP profile page.
The generic ingredient in PLAN B ONE-STEP is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
The generic ingredient in PLAN B ONE-STEP is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 021998
| Tradename: | PLAN B ONE-STEP |
| Applicant: | Fdn Consumer |
| Ingredient: | levonorgestrel |
| Patents: | 0 |
Pharmacology for NDA: 021998
| Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 021998
Suppliers and Packaging for NDA: 021998
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PLAN B ONE-STEP | levonorgestrel | TABLET;ORAL | 021998 | NDA | A-S Medication Solutions | 50090-5978 | 50090-5978-0 | 1 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5978-0) / 1 TABLET in 1 BLISTER PACK |
| PLAN B ONE-STEP | levonorgestrel | TABLET;ORAL | 021998 | NDA AUTHORIZED GENERIC | Foundation Consumer Healthcare LLC | 69536-103 | 69536-103-88 | 1 BLISTER PACK in 1 BOX, UNIT-DOSE (69536-103-88) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Jul 10, 2009 | TE: | RLD: | Yes | |||||
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