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Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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Approved Drug Products of Kv Pharmaceutical listed in the FDA Orange Book. Original Data : FDA Website

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01 ACETAMINOPHEN; CODEINE PHOSPHATE (4)

02 ACETIC ACID, GLACIAL (1)

03 ACETIC ACID, GLACIAL; HYDROCORTISONE (1)

04 AMINOPHYLLINE (2)

05 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE (1)

06 BROMPHENIRAMINE MALEATE (1)

07 CARBIDOPA; LEVODOPA (1)

08 CHLORPHENIRAMINE MALEATE (1)

09 CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE (1)

10 CHLORPROMAZINE HYDROCHLORIDE (5)

11 CHLORTHALIDONE (2)

12 CYPROHEPTADINE HYDROCHLORIDE (1)

13 DIPHENHYDRAMINE HYDROCHLORIDE (1)

14 ERGOLOID MESYLATES (4)

15 HYDROXYZINE HYDROCHLORIDE (5)

16 MECLIZINE HYDROCHLORIDE (2)

17 METHOCARBAMOL (2)

18 METHYLTESTOSTERONE (1)

19 PHENDIMETRAZINE TARTRATE (3)

20 POTASSIUM CHLORIDE (1)

21 PREDNISONE (1)

22 PROMETHAZINE HYDROCHLORIDE (2)

23 PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE (2)

24 QUINIDINE SULFATE (1)

25 SECOBARBITAL SODIUM (1)

26 THEOPHYLLINE (2)

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01 CAPSULE, EXTENDED RELEASE;ORAL (2)

02 CAPSULE;ORAL (3)

03 ELIXIR;ORAL (2)

04 FOR SUSPENSION, EXTENDED RELEASE;ORAL (1)

05 SOLUTION/DROPS;OTIC (2)

06 SYRUP;ORAL (3)

07 TABLET, EXTENDED RELEASE;ORAL (2)

08 TABLET;ORAL (30)

09 TABLET;SUBLINGUAL (4)

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01 0.025MG;2.5MG (1)

02 0.5MG (2)

03 100MG (5)

04 10MG (3)

05 10MG/5ML (1)

06 12.5MG (1)

07 12.5MG/5ML (1)

08 120MG;5MG (2)

09 12MG;120MG (1)

10 1MG (2)

11 2% (1)

12 2%;1% (1)

13 200MG (4)

14 20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

15 25MG (4)

16 25MG/5ML (1)

17 2MG/5ML (1)

18 300MG;30MG (1)

19 300MG;60MG (1)

20 325MG;15MG (1)

21 325MG;45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

22 35MG (3)

23 4MG (2)

24 500MG (1)

25 50MG (3)

26 50MG;200MG (1)

27 5MG (1)

28 6.25MG/5ML (1)

29 750MG (1)

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01 DISCN (49)

URL Supplier Web Content
TABLET; ORAL
300MG;30MG
1982-01-01
85288
ACETAMINOPHEN AND ...
DISCN
No
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TABLET; ORAL
325MG;45MG **Feder...
1982-01-01
85363
ACETAMINOPHEN AND ...
DISCN
No
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TABLET; ORAL
325MG;15MG
1982-01-01
85364
ACETAMINOPHEN AND ...
DISCN
No
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TABLET; ORAL
300MG;60MG
1982-01-01
85365
ACETAMINOPHEN AND ...
DISCN
No
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SOLUTION/DROPS; OT...
2%
1982-01-01
85493
ACETIC ACID
DISCN
No
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URL Supplier Web Content
SOLUTION/DROPS; OT...
2%;1%
1982-01-01
85492
ACETIC ACID W/ HYD...
DISCN
No
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URL Supplier Web Content
TABLET; ORAL
100MG
1982-01-01
85284
AMINOPHYLLINE
DISCN
No
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URL Supplier Web Content
TABLET; ORAL
200MG
1982-01-01
85289
AMINOPHYLLINE
DISCN
No
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URL Supplier Web Content
TABLET; ORAL
0.025MG;2.5MG
1982-01-01
85659
DIPHENOXYLATE HYDR...
DISCN
No
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ELIXIR; ORAL
2MG/5ML
1982-01-01
85466
BROMPHENIRAMINE MA...
DISCN
No
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