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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by PAR STERILE PRODUCTS
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
009402
DELESTROGEN
New Drug Application
Approval
011559
BREVITAL SODIUM
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
016812
KETALAR
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
017443
DANTRIUM
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
017530
TIGAN
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018261
PITOCIN
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018264
DANTRIUM
New Drug Application
Approval
New formulation
(P) Priority review drug
(V) Orphan drug
020105
TRIOSTAT
New Drug Application
Approval
New formulation
(P) Priority review drug
(V) Orphan drug
050108
COLY-MYCIN M
New Drug Application
Approval
076394
AMIODARONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077871
SUMATRIPTAN SUCCINATE
Abbreviated New Drug Application
Approval
091297
ETOMIDATE
Abbreviated New Drug Application
Approval
091665
ARGATROBAN
Abbreviated New Drug Application
Approval
203575
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
203732
FLUPHENAZINE DECANOATE
Abbreviated New Drug Application
Approval
203972
DEXMEDETOMIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
204139
MEROPENEM
Abbreviated New Drug Application
Approval
204200
ADRENALIN
New Drug Application
Approval
Drug already marketed, but without an approved NDA
(S) Standard review drug
204485
VASOSTRICT
New Drug Application
Approval
Drug already marketed, but without an approved NDA
(S) Standard review drug
204640
ADRENALIN
New Drug Application
Approval
Drug already marketed, but without an approved NDA
(S) Standard review drug
204773
MELPHALAN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
205366
LEVOTHYROXINE SODIUM
Abbreviated New Drug Application
Approval
205473
ETHACRYNATE SODIUM
Abbreviated New Drug Application
Approval
206586
BUPRENORPHINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
Back to Companies who have applied for FDA Drug Approval