FDA.reportPublic FDA data

ALLERGAN SALES, LLC

Matched from indexed company URL: ALLERGAN INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16435251643525ALLERGAN SALES, LLC1N2026-01-018301 MARS DR. WACO TX US 76712
20110682011068ALLERGAN SALES, LLC1Y2026-01-012525 DUPONT DR IRVINE CA US 92612
30112997513011299751ALLERGAN1N2020-04-25Building 3 12331-A Riata Trace Parkway Austin TX US 78727

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10888628032354Natrelle Inspira ST Resterilizable Sizers - Natrelle Inspira RS Sizer - ST X5458006244261ProductSupport@allergan.com
10888628032361Natrelle Inspira ST Resterilizable Sizers - Natrelle Inspira RS Sizer - ST X5608006244261ProductSupport@allergan.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2098701752192758P990074NATRELLE SALINE BREAST IMPLANTSFWM2000-05-10
45431752192758P990074NATRELLE SALINE BREAST IMPLANTSFWM2000-05-10
2098701487511073P110033JUVEDERM VOLUMA XCLMH2013-10-22
45431487511073P110033JUVEDERM VOLUMA XCLMH2013-10-22
2098701057618614P050047JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTSLMH2006-06-02
45431057618614P050047JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTSLMH2006-06-02
2098701988392864P040046NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTSFTR2013-02-20
45431988392864P040046NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTSFTR2013-02-20
2098701087648028P020056NATRELLE SILICONE-FILLED BREAST IMPLANTSFTR2006-11-17
45431087648028P020056NATRELLE SILICONE-FILLED BREAST IMPLANTSFTR2006-11-17
45421738697513K992028REFRESH CONTACTS LUBRICATING AND REWETTING DROPSLPN1999-10-07
45431738697513K992028REFRESH CONTACTS LUBRICATING AND REWETTING DROPSLPN1999-10-07
2098701689769887K942988FILTERED EXTENSION SETSFPA1995-07-14
45431689769887K942988FILTERED EXTENSION SETSFPA1995-07-14
2098701703051966K940986FLUTTER(R)BYI1994-05-24
45431703051966K940986FLUTTER(R)BYI1994-05-24
2098701138308571K865056CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDERLCJ1987-05-22
45431138308571K865056CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDERLCJ1987-05-22
2098701705756651K862203MCGHAN MAGNA-SITE(TM) TISSUE EXPANDERLCJ1986-07-23
45431705756651K862203MCGHAN MAGNA-SITE(TM) TISSUE EXPANDERLCJ1986-07-23
2098701683869254K853014MCGHAN TISSUE EXPANDER FILL KITLCJ1985-09-18
45431683869254K853014MCGHAN TISSUE EXPANDER FILL KITLCJ1985-09-18
45431735003550K831566CUI MAMMARY PROTHESIS SIZERMRD1983-08-12
2098701735003550K831566CUI MAMMARY PROTHESIS SIZERMRD1983-08-12
45431763441000K233804Resonic Rapid Acoustic Pulse DeviceGEX2024-02-01
45431751688231K233732CoolSculpting Elite SystemOOK2024-09-12
45431737038105K210964Resonic Rapid Acoustic Pulse DeviceGEX2021-04-27
45431586826399K203229NATRELLE INSPIRA Single Use Sizers for Gel ImplantsMRD2021-06-02
45431257688614K193566ZELTIQ CoolSculpting SystemOOK2020-01-21
45431880584960K192940CoolToneNGX2019-11-15
45431060753555K190674REFRESH RELIEVA For CONTACTSLPN2019-08-08
45431045210728K183514ZELTIQ CoolSculpting SystemOOK2019-01-14
45431942630938K182963emFieldProNGX2019-06-21
45431384183541K182054Natrelle 133S Tissue ExpanderLCJ2018-08-29
2098701384183541K182054Natrelle 133S Tissue ExpanderLCJ2018-08-29
45431484742527K181740ZELTIQ CoolSculpting SystemOOK2018-08-29
45431741539772K171069ZELTIQ CoolSculpting SystemOOK2017-07-07
2098701982092122K161483Unger Quad InjectorLCJ2016-10-31
45431982092122K161483Unger Quad InjectorLCJ2016-10-31
45431025235283K161457XEN Glaucoma Treatment SystemKYF2016-11-21
2098701025235283K161457XEN Glaucoma Treatment SystemKYF2016-11-21
45431526482961K160259ZELTIQ CoolSculpting SystemOOK2016-03-23
2098701648111475K143354Natrelle 133 Plus Tissue ExpanderLCJ2015-08-20
45431648111475K143354Natrelle 133 Plus Tissue ExpanderLCJ2015-08-20
45431366792579K102806NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABSLCJ2011-01-05
2098701366792579K102806NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABSLCJ2011-01-05
45431096674796K090094ZELTIQ SYSTEMGEX2009-05-20
45422055096840K083812REFRESH OPTIVE LENS COMFORT REWETTING DROPSLPN2009-07-09
45432055096840K083812REFRESH OPTIVE LENS COMFORT REWETTING DROPSLPN2009-07-09
2098702059755252DEN170086TrueTear Intranasal Tear NeurostimulatorQBR2018-05-17
2098701724251738DEN160030Oculeve Intranasal Tear Neurostimulator DevicePQJ2017-04-24
2098701249760156
2098701709671625
2098701982256655
45431249760156
45431709671625
45431937803557
45431982256655

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCJ142018-08-29
OOK62024-09-12
LPN52019-08-08
LMH42013-10-22
FTR42013-02-20
GEX32024-02-01
MRD32021-06-02
NGX22019-11-15
KYF22016-11-21
FWM22000-05-10
FPA21995-07-14
BYI21994-05-24
QBR12018-05-17
PQJ12017-04-24

NDC#

BOTOX

Allergan, Inc.

onabotulinumtoxinA

Acular

Allergan, Inc.

Ketorolac Tromethamine

REFRESH OPTIVE

Allergan, Inc.

carboxymethylcellulose sodium and glycerin

ACUVAIL

Allergan, Inc.

ketorolac tromethamine

BOTOX

Allergan, Inc.

onabotulinumtoxinA

LILETTA

Allergan, Inc.

Levonorgestrel

137 records. Showing 1-40. Next

PMA#

NATRELLE Saline-Filled Breast Implants

2022-12-29

Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP990074 Supplement NumberS050 Date Received04/04/2022 Decision Date12/29/2022 Product Code FWM  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Labeling Change...

NATRELLE Silicone-Filled Breast Implants

2022-12-29

Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP020056 Supplement NumberS059 Date Received04/04/2022 Decision Date12/29/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Labeling Change...

NATRELLE Silicone-Filled Breast Implants

2022-10-05

Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP990074 Supplement NumberS049 Date Received04/01/2022 Decision Date10/05/2022 Product Code FWM  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reaso...

NATRELLE Saline-Filled Breast Implants

2022-10-05

Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP020056 Supplement NumberS058 Date Received04/01/2022 Decision Date10/05/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reaso...

Voluma XC, Vollure XC, Volbella XC

2022-08-05

Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP110033 Supplement NumberS067 Date Received07/07/2022 Decision Date08/05/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Juvéderm Ultra, Ultra XC, Juvéderm Ultra XC

2022-08-05

Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP050047 Supplement NumberS086 Date Received07/07/2022 Decision Date08/05/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC

2022-04-28

Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP110033 Supplement NumberS066 Date Received04/01/2022 Decision Date04/28/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Juvéderm Ultra, Ultra XC and Ultra Plus XC, Juvéderm Ultra XC

2022-04-28

Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP050047 Supplement NumberS085 Date Received04/01/2022 Decision Date04/28/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Ma...

200 records. Showing 1-40. Next

PMN#

52 records. Showing 1-40. Next

Applications#

124 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next