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Approved Drug Products of Assertio Therapeutics listed in the FDA Orange Book. Original Data : FDA Website

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01 DICLOFENAC (2)

02 INDOMETHACIN (5)

03 KETOROLAC TROMETHAMINE (1)

04 MORPHINE SULFATE (3)

05 OXYCODONE HYDROCHLORIDE (2)

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01 CAPSULE, EXTENDED RELEASE;ORAL (1)

02 CAPSULE;ORAL (4)

03 SPRAY, METERED;NASAL (1)

04 SUPPOSITORY;RECTAL (1)

05 SUSPENSION;ORAL (1)

06 TABLET, EXTENDED RELEASE;ORAL (3)

07 TABLET;ORAL (2)

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01 15.75MG/SPRAY (1)

02 15MG (1)

03 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

04 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

05 25MG/5ML (1)

06 30MG (1)

07 35MG (1)

08 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (2)

09 5MG (1)

10 60MG (1)

11 7.5MG (1)

12 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

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01 DISCN (11)

02 RX (2)

URL Supplier Web Content
CAPSULE; ORAL
18MG **Federal Reg...
2013-10-18
204592
ZORVOLEX
DISCN
Yes
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CAPSULE; ORAL
35MG
2013-10-18
204592
ZORVOLEX
DISCN
Yes
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CAPSULE; ORAL
25MG **Federal Reg...
1982-01-01
16059
INDOCIN
DISCN
Yes
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CAPSULE; ORAL
50MG **Federal Reg...
1982-01-01
16059
INDOCIN
DISCN
Yes
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SUPPOSITORY; RECTA...
50MG **Federal Reg...
1984-08-13
17814
INDOCIN
DISCN
Yes
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CAPSULE, EXTENDED ...
75MG **Federal Reg...
1982-02-23
18185
INDOCIN SR
DISCN
Yes
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SUSPENSION; ORAL
25MG/5ML
1985-10-10
18332
INDOCIN
RX
Yes
AB
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SPRAY, METERED; NA...
15.75MG/SPRAY
2010-05-14
22382
SPRIX
RX
Yes
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TABLET, EXTENDED R...
15MG
2017-01-09
208603
ARYMO ER
DISCN
Yes
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TABLET, EXTENDED R...
30MG
2017-01-09
208603
ARYMO ER
DISCN
Yes
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