01 4ALVOGEN
02 3ANDAS 5 HOLDING
03 4APOTHECON
04 4APPCO
05 1BAXTER HLTHCARE CORP
06 3CADILA PHARMS LTD
07 1CAPLIN
08 3ENDO OPERATIONS
09 3EPIC PHARMA LLC
10 1GLAND PHARMA LTD
11 4GLAXOSMITHKLINE
12 3HERITAGE PHARMA
13 3HIBROW HLTHCARE
14 7HIKMA
15 3HOSPIRA
16 1ONESOURCE SPECIALTY
17 2RISING
18 3RUBICON
19 3SANDOZ
20 9SCHERING
21 1SEBELA IRELAND LTD
22 3TEVA
23 3UNICHEM
24 3WATSON LABS
25 3ZYDUS PHARMS
01 13INJECTABLE;INJECTION
02 6SOLUTION;INTRAVENOUS
03 59TABLET;ORAL
01 32DISCN
02 46RX
01 56LABETALOL HYDROCHLORIDE
02 1LABETALOL HYDROCHLORIDE IN DEXTROSE
03 3LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE
04 5NORMODYNE
05 4NORMOZIDE
06 5TRANDATE
07 4TRANDATE HCT
01 62No
02 16Yes
RLD : Yes
TE Code :
Brand Name : TRANDATE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1985-05-24
Application Number : 18716
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : TRANDATE
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18716
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : TRANDATE
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18716
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : TRANDATE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18716
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NORMODYNE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18686
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NORMODYNE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1987-08-31
Application Number : 18687
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NORMODYNE
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18687
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NORMODYNE
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18687
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NORMODYNE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18687
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
Brand Name : NORMOZIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 25MG;100MG
Approval Date : 1987-04-06
Application Number : 19046
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
