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01 1DALBAVANCIN HYDROCHLORIDE
02 1DOXYCYCLINE HYCLATE
03 2FLUOROURACIL
04 1HYDRALAZINE HYDROCHLORIDE
05 7ROPIVACAINE HYDROCHLORIDE
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01 4INJECTABLE;INJECTION
02 1POWDER;INTRAVENOUS
03 7SOLUTION;INJECTION
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01 1100MG/10ML (10MG/ML)
02 1100MG/20ML (5MG/ML)
03 1150MG/20ML (7.5MG/ML)
04 1150MG/30ML (5MG/ML)
05 12.5GM/50ML (50MG/ML)
06 1200MG/20ML (10MG/ML)
07 120MG/10ML (2MG/ML)
08 120MG/ML
09 140MG/20ML (2MG/ML)
10 15GM/100ML (50MG/ML)
11 1EQ 100MG BASE/VIAL
12 1EQ 500MG BASE/VIAL
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01 12RX
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RLD : No
TE Code : AP
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : DALBAVANCIN HYDROCHLORID...
Dosage Strength : EQ 500MG BASE/VIAL
Approval Date : 2025-11-26
Application Number : 218929
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : DOXYCYCLINE HYCLATE
Dosage Strength : EQ 100MG BASE/VIAL
Approval Date : 2024-10-28
Application Number : 218053
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : FLUOROURACIL
Dosage Strength : 5GM/100ML (50MG/ML)
Approval Date : 2025-02-06
Application Number : 215699
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : FLUOROURACIL
Dosage Strength : 2.5GM/50ML (50MG/ML)
Approval Date : 2024-09-24
Application Number : 216494
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : HYDRALAZINE HYDROCHLORID...
Dosage Strength : 20MG/ML
Approval Date : 2025-06-02
Application Number : 217501
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : SOLUTION; INJECTION
Proprietary Name : ROPIVACAINE HYDROCHLORID...
Dosage Strength : 20MG/10ML (2MG/ML)
Approval Date : 2024-07-30
Application Number : 218713
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : SOLUTION; INJECTION
Proprietary Name : ROPIVACAINE HYDROCHLORID...
Dosage Strength : 40MG/20ML (2MG/ML)
Approval Date : 2024-07-30
Application Number : 218713
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : SOLUTION; INJECTION
Proprietary Name : ROPIVACAINE HYDROCHLORID...
Dosage Strength : 100MG/20ML (5MG/ML)
Approval Date : 2024-07-30
Application Number : 218713
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : SOLUTION; INJECTION
Proprietary Name : ROPIVACAINE HYDROCHLORID...
Dosage Strength : 100MG/10ML (10MG/ML)
Approval Date : 2024-07-30
Application Number : 218713
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : SOLUTION; INJECTION
Proprietary Name : ROPIVACAINE HYDROCHLORID...
Dosage Strength : 150MG/30ML (5MG/ML)
Approval Date : 2024-07-30
Application Number : 218713
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
