OVAPLANT-L- almon gonadotropin-releasing hormone analog liquid, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SALMON GONADOTROPIN RELEASING HORMONE D-ARG6 ANALOG ETHYL AMIDE ACETATE (UNII: 66KW0E903I) (SALMON GONADOTROPIN RELEASING HORMONE D-ARG6 ANALOG ETHYL AMIDE - UNII:WHI058YG4Q)

Available from:

Western Chemical Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

OTC

Authorization status:

Export only

Summary of Product characteristics

OVAPLANT-L- ALMON GONADOTROPIN-RELEASING HORMONE ANALOG LIQUID,
EXTENDED
RELEASE
WESTERN CHEMICAL INC.
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OVAPLANT-L
OVAPLANT-L.JPG
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OVAPLANT-L
almon gonadotropin-releasing hormone analog liquid, extended release
PRODUCT INFORMATION
PRODUCT TYPE
OTC ANIMAL DRUG
ITEM CODE (SOURCE)
NDC:50378-017
ROUTE OF ADMINISTRATION
INTRAMUSCULAR
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SALMON GONADOTROPIN RELEASING HORMONE D-ARG6 ANALOG
ETHYL AMIDE ACETATE (UNII: 66KW0E903I) (SALMON GONADOTROPIN
RELEASING HORMONE D-ARG6 ANALOG ETHYL AMIDE - UNII:WHI058YG4Q)
SALMON GONADOTROPIN
RELEASING HORMONE D-ARG6
ANALOG ETHYL AMIDE
ACETATE
0.002 g
in 1 mL
Western Chemical Inc.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SUCROSE ACETATE ISOBUTYRATE (UNII: H5KI1C3YTV)
14 g in 1 mL
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
6 g in 1 mL
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1 NDC:50378-017-01
20 mL in 1 VIAL, GLASS
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
export only
06/22/2023
LABELER -
Western Chemical Inc. (085803500)
REGISTRANT -
Western Chemical Inc. (085803500)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Western Chemical Inc.
085803500
label
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
BCN Peptides SA
468203687
api manufacture
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Thorn BioScience
017993556
manufacture, analysis, pack
Revised: 6/2023