Natchez Animal Supply Company
...Testing and release of the drug product for distribution do not include appropriate laboratory.....The veterinary drug product manufactured by your firm also is misbranded under Section 502.....Such deviations cause your aquaculture drug, Formalin-F, to be adulterated within the..
http://www.fda.gov/foi/warning_letters/g3543d.htm (score=100)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....establish a set of criteria to which a drug substance or drug product should conform using.....This guidance has been prepared by the Inhalation Drug Products Working Group of the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=97)

...Three comments concerned the proposed exemption of drug product salvagers from drug listing in.....He does not agree that drug product salvaging should be prohibited where the integrity of the.....Amendments Regarding Drug Listing and Establishment Registration Requirements for Drug Product..
http://www.fda.gov/cder/dmpq/preamble.txt (score=85)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...Drug product containers and closures play a critical role in assuring that the drug product.....Quarantine areas should be set up to separate the incoming drug product, incoming cylinders and.....There must be written procedures to assure that the correct label is used on the drug product..
http://www.fda.gov/cder/dmpq/freshair.htm (score=77)

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...18 The applicant and/or drug product manufacturer must establish the reliability of the.....associated acceptance criteria depend on the route of administration of the drug product and.....its specification and, therefore, can be used in the manufacture of a given drug product..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=77)

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...18 The applicant and/or drug product manufacturer must establish the reliability of the.....associated acceptance criteria depend on the route of administration of the drug product and.....its specification and, therefore, can be used in the manufacture of a given drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=74)

...If a drug product, or change to a drug product, is given 3 years of exclusivity, we are barred for 3 years from approving.....Types of NDAs for Ca-DTPA and Zn-DTPA An NDA for a Ca-DTPA or Zn-DTPA drug product may be.....Because we have not previously approved a drug product that contains the DTPA ligand as the..
http://www.fda.gov/cder/guidance/6455fnl.doc (score=74)

Human Drug Product Not Equivalent to Veterinary Ceftiofur
...Claims that cefazolin and ceftiofur are equivalent not only misbrands the human product.....HUMAN DRUG PRODUCT NOT EQUIVALENT TO VETERINARY CEFTIOFUR.. FDA continues to receive reports.....drug product Naxcel (ceftiofur sodium). In 1996, letters were sent to all known..
http://www.fda.gov/cvm/index/updates/ceftiofur.html (score=71)

Guideline for Submitting Supporting Documentation
...Approval of reprocessing procedures must be obtained before release of the reprocessed drug or drug.....List all substances used in the manufacture of a drug product whether or not they appear in the.....To facilitate the evaluation of the production and control of the drug product, submit a copy..
http://www.fda.gov/cder/guidance/drugprod.htm (score=71)

ANDA/AADA
...Once approved an applicant may manufacture and market the generic drug product provided all.....These parameters were established upon the approval of the innovator drug product, which is the.....It contains data which when submitted to FDA's Center for Drug Evaluation and Research..
http://www.fda.gov/cder/handbook/andabox.htm (score=71)

Therapeutic Equivalence of Generic Drugs Letter
...FDA works with both brand-name and generic drug product manufacturers after a drug product is in the marketplace to assure its.....For example, brand-name and generic drug product manufacturers may want to change the drug.....In approving a generic drug product, the FDA requires many rigorous tests and procedures to..
http://www.fda.gov/cder/news/nightgenlett.htm (score=71)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process.....A critical area is one in which the sterilized drug product, containers, and closures are..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=68)

Prescription and OTC Drug Product List 6/2000
...Prescription and Over-the-Counter Drug Product List - 20th Edition.. Cumulative Supplement.....Prescription - OTC] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST.. ACETOHEXAMIDE.....ADDITIONS/DELETIONS FOR OTC DRUG PRODUCT LIST .. No updates. CDER Home Page | Search..
http://www.fda.gov/cder/rxotcdpl/pdpl_200006.htm (score=68)

Sterile Drug Products Produced by Aseptic Processing
...Drug product containers and closures shall be clean and, where indicated by the nature of the.....Drug product containers and closures shall be clean and, where indicated by the nature of the.....In an aseptic process, the drug product, container, and closure are first subjected to..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=63)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process.....A critical area is one in which the sterilized drug product, containers, and closures are..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=63)

Prescription and OTC Drug Product List
...PRESCRIPTION DRUG PRODUCT LIST 17TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST.....Prescription and Over-the-Counter Drug Product List - 17th Edition.. Cumulative Supplement.....ADDITIONS/DELETIONS FOR OTC DRUG PRODUCT LIST .. CHLORHEXIDINE GLUCONATE SOLUTION; TOPICAL..
http://www.fda.gov/cder/rxotcdpl/pdpl997.htm (score=63)

FOIA WARNING LETTERS SEARCH
...New Animal Drug Product.. Hollandia Farms, Inc. 6/13/97.. San Francisco District Office.. View.....New Animal Drug Product.. Mortar & Pestle Pharmacy, Inc. 6/13/97.. Kansas City District.....New Animal Drug Product.. Simoes, Mario M. 7/17/97.. San Francisco District Office.. View..
http://www.fda.gov/foi/sub329.htm (score=63)

Drugs@FDA: Glossary of Terms
...Once approved, an applicant may manufacture and market the generic drug product to provide a.....The approval history is a chronological list of all FDA actions involving one drug product.....Before approving a generic drug product, FDA requires many rigorous tests and procedures to..
http://www.fda.gov/cder/drugsatfda/glossary.htm (score=60)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....Ordinarily, the approved expiration dating period for the drug product may be retained if the.....A new dosage form is defined as a drug product that is a different pharmaceutical product type..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=60)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug.....testing, all end-product tests should be completed or in progress at the time of shipment..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=57)

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