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Approved Drug Products containing Labetalol Hydrochloride listed in the FDA Orange Book. Original Data : FDA Website

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01 ALVOGEN (4)

02 APOTHECON (4)

03 APPCO (3)

04 BAXTER HLTHCARE CORP (1)

05 CADILA PHARMS LTD (3)

06 CAPLIN (1)

07 EPIC PHARMA LLC (3)

08 EYWA (3)

09 GLAND PHARMA LTD (1)

10 GLAXOSMITHKLINE (4)

11 HERITAGE PHARMA (3)

12 HIKMA (6)

13 HOSPIRA (3)

14 INNOGENIX (3)

15 PAR FORM (3)

16 RISING (2)

17 RUBICON (3)

18 SANDOZ (3)

19 SCHERING (9)

20 SEBELA IRELAND LTD (1)

21 STERISCIENCE (1)

22 TEVA (3)

23 UNICHEM (3)

24 WATSON LABS (3)

25 ZYDUS PHARMS (3)

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01 INJECTABLE;INJECTION (13)

02 SOLUTION;INTRAVENOUS (5)

03 TABLET;ORAL (58)

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01 DISCN (31)

02 RX (45)

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01 LABETALOL HYDROCHLORIDE (54)

02 LABETALOL HYDROCHLORIDE IN DEXTROSE (1)

03 LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE (3)

04 NORMODYNE (5)

05 NORMOZIDE (4)

06 TRANDATE (5)

07 TRANDATE HCT (4)

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01 No (61)

02 Yes (15)

URL Supplier Web Content
TABLET;ORAL
100MG
1985-05-24
18716
TRANDATE
DISCN
Yes
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TABLET;ORAL
200MG
1984-08-01
18716
TRANDATE
DISCN
Yes
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TABLET;ORAL
300MG
1984-08-01
18716
TRANDATE
DISCN
Yes
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TABLET;ORAL
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1984-08-01
18716
TRANDATE
DISCN
Yes
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INJECTABLE;INJECTION
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1984-08-01
18686
NORMODYNE
DISCN
Yes
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TABLET;ORAL
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1987-08-31
18687
NORMODYNE
DISCN
Yes
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TABLET;ORAL
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1984-08-01
18687
NORMODYNE
DISCN
Yes
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TABLET;ORAL
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1984-08-01
18687
NORMODYNE
DISCN
Yes
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TABLET;ORAL
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1984-08-01
18687
NORMODYNE
DISCN
Yes
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TABLET;ORAL
25MG;100MG
1987-04-06
19046
NORMOZIDE
DISCN
No
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