WELLBUTRIN
bupropion hydrochloride
GlaxoSmithKline Consumer Heatlhcare LP
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1062634 | 3003508968 | GlaxoSmithKline Consumer Heatlhcare LP | 1 | Y | 2020-04-25 | 4480 Swinnea Rd MEMPHIS TN US 38118 |
| 2950935 | 1000142582 | GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. | 1 | Y | 2020-04-25 | 2020 E. VINE AVE. FRESNO CA US 93706 |
| 3008316718 | 3008316718 | GlaxoSmithKline Consumer Healthcare LP | 1 | Y | 2020-04-25 | 115 Willow Springs Ln York PA US 17406 |
| 3008365414 | 3008365414 | GlaxoSmithKline Consumer Healthcare LP | 1 | Y | 2020-04-25 | Rd. #1 Km 21.1 c/o Ceasar Castillo Inc. Guaynabo PR US 00970 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 7516 | 1417949907 | K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY | LFD | 2013-01-04 |
| 142174 | 1417949907 | K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY | LFD | 2013-01-04 |
| 7516 | 1656416605 | K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF | LFD | 2011-07-20 |
| 142174 | 1656416605 | K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF | LFD | 2011-07-20 |
| 7516 | 1842604639 | K061331 | ORAL BALANCE LIQUID/ GEL | LFD | 2006-07-25 |
| 142174 | 1842604639 | K061331 | ORAL BALANCE LIQUID/ GEL | LFD | 2006-07-25 |
| 142174 | 1143669791 | ||||
| 7516 | 1268529098 | ||||
| 142174 | 1268529098 | ||||
| 7516 | 1635559116 | ||||
| 142174 | 1635559116 | ||||
| 7516 | 1795115566 | ||||
| 142174 | 1795115566 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LFD | 6 | 2013-01-04 |
NDC#
IMITREX
sumatriptan
IMITREX
sumatriptan
FLOLAN
epoprostenol sodium
SEREVENT
salmeterol xinafoate
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
MEPRON
atovaquone
VALTREX
valacyclovir hydrochloride
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
MEPRON
atovaquone
MALARONE
atovaquone and proguanil hydrochloride
MALARONE
atovaquone and proguanil hydrochloride
RELENZA
zanamivir
VENTOLIN
albuterol sulfate
ADVAIR
fluticasone propionate and salmeterol
ADVAIR
fluticasone propionate and salmeterol
ADVAIR
fluticasone propionate and salmeterol
LAMICTAL
lamotrigine
ADVAIR HFA
fluticasone propionate and salmeterol xinafoate
ADVAIR HFA
fluticasone propionate and salmeterol xinafoate
ADVAIR HFA
fluticasone propionate and salmeterol xinafoate
WELLBUTRIN
bupropion hydrochloride
IMITREX
sumatriptan
IMITREX
sumatriptan
IMITREX
sumatriptan
IMITREX
sumatriptan
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
LAMICTAL
lamotrigine
PMN#
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
ACTIPROTECT UC N95 RESPIRATOR
GLAXOSMITHKLINE CONSUMER HEALTHCARE
ACTIPROTECT UF N95 RESPIRATOR
GLAXOSMITHKLINE CONSUMER HEALTHCARE
ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
GLAXOSMITHKLINE CONSUMER HEALTHCARE
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.