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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Organica Feinchemie Gmbh Wolfen to the U.S. FDA. Original Data : FDA Website

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01 AMINOBISAMIDE HYDROCHLORIDE (2)

02 DIATRIZOATE MEGLUMINE USP (1)

03 DIATRIZOATE SODIUM U.S.R. (1)

04 ENCAINIDE HCl (1)

05 FLOXURIDINE (1)

06 HYDROCORTISONE-17-VALERATE (1)

07 HYPERPOLARIZED HELIUM-3 GAS (HP-3HE) (1)

08 INDOCYANINE GREEN DRUG SUBSTANCE (1)

09 PHENYLEPHIRINE OXAZOLIDINE (1)

10 PHENYLEPHRINE HCL USP (1)

11 PODOPHYLLOTOXIN (1)

12 SR-2508, HYPOXIC CELL RADIOSENSITIZER (1)

13 STRONTIUM 87M GENERATOR (1)

14 SUPROFEN (1)

15 TOLMETIN SODIUM DIHYDRATE (1)

16 TRIETHYLENETETRAMINE DIHYDROCHLORIDE (TRIENE) (1)

17 TRIHEXYPHENIDYL HCL (1)

18 ZOMEPIRAC SODIUM DIHYDRATE (1)

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01 NYCOMED AUSTRIA GMBH (1)

02 ORGANICHEM CORP (17)

03 WEYLCHEM ORGANICA GMBH (1)

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01 Germany (19)

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01 Active (1)

02 Inactive (18)

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01 Complete (1)

02 Blank (18)

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ORGANICHEM CORP
Inactive
4686
N/A
1982-10-15
II
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ORGANICHEM CORP
Inactive
4731
N/A
1982-11-30
II
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ORGANICHEM CORP
Inactive
5176
N/A
1983-12-19
II
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NYCOMED AUSTRIA GMBH
Inactive
14006
N/A
1999-03-08
II
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ORGANICHEM CORP
Inactive
2493
N/A
1975-07-18
II
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ORGANICHEM CORP
Inactive
13924
N/A
1998-12-30
II
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WEYLCHEM ORGANICA GMB...
Active
19601
Complete
2021-12-05
2021-11-30
2006-07-13
II
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ORGANICHEM CORP
Inactive
7785
N/A
1988-12-06
II
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ORGANICHEM CORP
Inactive
5073
N/A
1983-07-15
II
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ORGANICHEM CORP
Inactive
8969
N/A
1991-02-15
II
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