AMBROXOL HCI, EP8.0 powder
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
21-11-2018
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Active ingredient:
AMBROXOL HYDROCHLORIDE (UNII: CC995ZMV90) (AMBROXOL - UNII:200168S0CL)
Available from:
AX Pharmaceutical Corp
Administration route:
NOT APPLICABLE
Authorization status:
Bulk Ingredient For Animal Drug Compounding
Summary of Product characteristics
AMBROXOL HCI, EP8.0- AMBROXOL HCI, EP8.0 POWDER
AX PHARMACEUTICAL CORP
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PRODUCT LABEL
AMBROXOL HCI, EP8.0
ambroxol hci, ep8.0 powder
PRODUCT INFORMATION
PRODUCT T YPE
BULK INGREDIENT
ITE M CODE (SOURCE )
NDC:6 2157-721
ROUTE OF ADMINISTRATION
NOT APPLICABLE
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
AMBRO XO L HYDRO CHLO RIDE (UNII: CC9 9 5ZMV9 0 ) (AMBROXOL -
UNII:20 0 16 8 S0 CL)
AMBROXOL
HYDROCHLORIDE
1 g in 1 g
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 2157-721-0 1
10 0 g in 1 JAR
11/21/20 18
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH
CITA TIO N
MARKE TING START
DATE
MARKE TING END
DATE
bulk ingredient fo r animal drug
c o mpo unding
11/21/20 18
AX Pharmaceutical Corp
LABELER -
AX Pharmaceutical Corp (202924858)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Hangzho u Deli Chemical Co ., Ltd
546 30 9 0 35
ma nufa c ture (6 2157-721)
Revised: 11/2018
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