NDC 10885-002

Synera

Lidocaine And Tetracaine

Synera is a Cutaneous Patch in the Human Prescription Drug category. It is labeled and distributed by Galen Us Incorporated. The primary component is Lidocaine; Tetracaine.

Product ID10885-002_7aa261d1-15a8-e0ab-e053-2a91aa0ad2a0
NDC10885-002
Product TypeHuman Prescription Drug
Proprietary NameSynera
Generic NameLidocaine And Tetracaine
Dosage FormPatch
Route of AdministrationCUTANEOUS
Marketing Start Date2013-12-01
Marketing CategoryNDA / NDA
Application NumberNDA021623
Labeler NameGalen US Incorporated
Substance NameLIDOCAINE; TETRACAINE
Active Ingredient Strength70 mg/1; mg/1
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10885-002-01

1 PATCH in 1 POUCH (10885-002-01)
Marketing Start Date2013-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10885-002-01 [10885000201]

Synera PATCH
Marketing CategoryNDA
Application NumberNDA021623
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-01

NDC 10885-002-10 [10885000210]

Synera PATCH
Marketing CategoryNDA
Application NumberNDA021623
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-01

Drug Details

Active Ingredients

IngredientStrength
LIDOCAINE70 mg/1

OpenFDA Data

SPL SET ID:5f86a348-2274-4945-8694-4c1f0050bf02
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 644287
  • 644290
  • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Antiarrhythmic [EPC]
    • Local Anesthesia [PE]
    • Esters [CS]
    • Local Anesthesia [PE]
    • Ester Local Anesthetic [EPC]
    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Antiarrhythmic [EPC]
    • Local Anesthesia [PE]
    • Esters [CS]
    • Local Anesthesia [PE]
    • Ester Local Anesthetic [EPC]

    NDC Crossover Matching brand name "Synera" or generic name "Lidocaine And Tetracaine"

    NDCBrand NameGeneric Name
    10885-002Syneralidocaine and tetracaine
    69420-3077LIDOCAINE AND TETRACAINELIDOCAINE AND TETRACAINE
    71800-631Lidocaine and TetracaineLidocaine and Tetracaine
    0299-6100PLIAGLISlidocaine and tetracaine
    51672-5305PLIAGLISLidocaine and Tetracaine
    73575-009Pliaglislidocaine and tetracaine
    73575-010Pliaglislidocaine and tetracaine

    Trademark Results [Synera]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYNERA
    SYNERA
    79350589 not registered Live/Pending
    Elise GmbH
    2022-08-15
    SYNERA
    SYNERA
    78632294 3231128 Live/Registered
    GALEN SPECIALTY PHARMA US LLC
    2005-05-18
    SYNERA
    SYNERA
    76667214 3296134 Dead/Cancelled
    GALEN SPECIALTY PHARMA US LLC
    2006-10-10
    SYNERA
    SYNERA
    76667213 not registered Dead/Abandoned
    Zars, Inc.
    2006-10-10
    SYNERA
    SYNERA
    76180651 2703649 Dead/Cancelled
    Synera Systems, S.L.
    2000-12-14
    SYNERA
    SYNERA
    75559446 not registered Dead/Abandoned
    MUTUAL LIFE ASSURANCE COMPANY OF CANADA, THE
    1998-09-22
    SYNERA
    SYNERA
    75162172 not registered Dead/Abandoned
    Packard Bell NEC, Inc.
    1996-09-06
    SYNERA
    SYNERA
    73475359 1320893 Dead/Cancelled
    Amoco Fabrics Company
    1984-04-13
    SYNERA
    SYNERA
    73475358 1320807 Dead/Cancelled
    Amoco Fabrics Company
    1984-04-13

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.