Apo-hepat

Chionanthus Virginicus Bark, Iberis Amara Seed, Lycopodium Clavatum Spore, Mandragora Officinarum Root, Phosphorus, Peumus Boldus Leaf, Cynara Scolymus Whole, And Taraxacum Officinale Whole


Pekana Naturheilmittel Gmbh
Human Otc Drug
NDC 59469-106
Apo-hepat also known as Chionanthus Virginicus Bark, Iberis Amara Seed, Lycopodium Clavatum Spore, Mandragora Officinarum Root, Phosphorus, Peumus Boldus Leaf, Cynara Scolymus Whole, And Taraxacum Officinale Whole is a human otc drug labeled by 'Pekana Naturheilmittel Gmbh'. National Drug Code (NDC) number for Apo-hepat is 59469-106. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Apo-hepat drug includes Chionanthus Virginicus Root Bark - 2 [hp_X]/50mL Cynara Scolymus Whole - 8 [hp_X]/50mL Iberis Amara Seed - 6 [hp_X]/50mL Lycopodium Clavatum Spore - 4 [hp_X]/50mL Mandragora Officinarum Root - 12 [hp_X]/50mL Peumus Boldus Leaf - 6 [hp_X]/50mL Phosphorus - 10 [hp_X]/50mL Taraxacum Officinale Whole - 8 [hp_X]/50mL . The currest status of Apo-hepat drug is Active.

Drug Information:

Drug NDC: 59469-106
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Apo-hepat
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Chionanthus Virginicus Bark, Iberis Amara Seed, Lycopodium Clavatum Spore, Mandragora Officinarum Root, Phosphorus, Peumus Boldus Leaf, Cynara Scolymus Whole, And Taraxacum Officinale Whole
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Pekana Naturheilmittel Gmbh
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Solution/ Drops
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:CHIONANTHUS VIRGINICUS ROOT BARK - 2 [hp_X]/50mL
CYNARA SCOLYMUS WHOLE - 8 [hp_X]/50mL
IBERIS AMARA SEED - 6 [hp_X]/50mL
LYCOPODIUM CLAVATUM SPORE - 4 [hp_X]/50mL
MANDRAGORA OFFICINARUM ROOT - 12 [hp_X]/50mL
PEUMUS BOLDUS LEAF - 6 [hp_X]/50mL
PHOSPHORUS - 10 [hp_X]/50mL
TARAXACUM OFFICINALE WHOLE - 8 [hp_X]/50mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 12 Apr, 2008
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 10 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:PEKANA Naturheilmittel GmbH
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:S9Y4B22U2E
9N3437ZUU0
T90A7M66YF
C88X29Y479
I2XCB174VB
Q4EWM09M3O
27YLU75U4W
7C42E2D7B0
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
59469-106-101 BOTTLE, GLASS in 1 BOX (59469-106-10) / 50 mL in 1 BOTTLE, GLASS04 Dec, 2008N/ANo
59469-106-401 BOTTLE, GLASS in 1 BOX (59469-106-40) / 100 mL in 1 BOTTLE, GLASS04 Dec, 2008N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Helps cleanse and detoxify the body. application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. with severe forms of this disease, a clinically proven therapy is indicated.

Product Elements:

Apo-hepat chionanthus virginicus bark, iberis amara seed, lycopodium clavatum spore, mandragora officinarum root, phosphorus, peumus boldus leaf, cynara scolymus whole, and taraxacum officinale whole chionanthus virginicus root bark chionanthus virginicus root bark iberis amara seed iberis amara seed lycopodium clavatum spore lycopodium clavatum spore mandragora officinarum root mandragora officinarum root phosphorus phosphorus peumus boldus leaf peumus boldus leaf cynara scolymus whole cynara scolymus whole taraxacum officinale whole taraxacum officinale whole water alcohol

Indications and Usage:

Indications helps cleanse and detoxify the body. application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. with severe forms of this disease, a clinically proven therapy is indicated.

Warnings:

Warning if symptoms persist, contact a licensed practitioner. if you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. if you are pregnant or nursing a baby, seek the advice of a health care professional before use. keep out of the reach of children. protect from light and heat. tamper evident do not use this product if tamper evident strip is broken or removed from base of cap.

Dosage and Administration:

Dosage unless otherwise prescribed, adults take 15-20 drops, 3 times per day. for pediatric dosages, consult your practitioner.

Package Label Principal Display Panel:

Principal display panel - 100 ml bottle box apo-hepat™ oral drops homeopathic medicine helps cleanse and detoxify the body 3.34 fl oz (100 ml) pekana ® principal display panel - 100 ml bottle box

Further Questions:

To report adverse events, contact bioresource at 321b blodgett street, cotati, ca 94931


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.