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01 1AMPHASTAR PHARMS INC
02 1GLAND
03 1LUPIN LTD
04 1MEITHEAL
05 1ORGANON USA ORGANON
06 1QILU
07 1SUN PHARM
08 1TRIS PHARMA INC
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01 8INJECTABLE;INJECTION
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01 8RX
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01 1FYREMADEL
02 7GANIRELIX ACETATE
01 7No
02 1Yes
RLD : No
TE Code : AP
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Approval Date : 2022-04-07
Application Number : 212613
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Approval Date : 2023-02-28
Application Number : 215658
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Approval Date : 2023-11-16
Application Number : 216075
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Approval Date : 2022-06-06
Application Number : 214996
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Approval Date : 1999-07-29
Application Number : 21057
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : No
TE Code : AP
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Approval Date : 2025-04-23
Application Number : 218855
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : FYREMADEL
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Approval Date : 2018-11-30
Application Number : 204246
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Approval Date : 2025-06-27
Application Number : 219454
RX/OTC/DISCN : RX
RLD : No
TE Code : AP