01 6BRECKENRIDGE
02 6MANKIND PHARMA
03 4SCHERING
04 6ACCORD HLTHCARE
05 6AIPING PHARM INC
06 4AM THERAP
07 4ANI PHARMS
08 1ANI PHARMS INC
09 7ASTRAZENECA
10 6AUROBINDO PHARMA USA
11 5BRISTOL MYERS SQUIBB
12 9CHARTWELL RX
13 6COPLEY PHARM
14 4FOSUN PHARMA
15 6HALSEY
16 2HERITAGE PHARMA
17 5IVAX SUB TEVA PHARMS
18 11LEDERLE
19 2MICRO LABS
20 8MUTUAL PHARM
21 15MYLAN
22 2MYLAN PHARMS INC
23 5NEW RIVER
24 11PAR PHARM
25 6PH HEALTH
26 6PLIVA
27 10PUREPAC PHARM
28 6RISING
29 7ROCHE
30 12ROXANE
31 6RUBICON RESEARCH
32 7SANDOZ
33 12SUN PHARM INDS INC
34 4SUN PHARM INDUSTRIES
35 5SUPERPHARM
36 7TEVA
37 2TP ANDA HOLDINGS
38 6UCB INC
39 6UNICHEM
40 6UNIQUE PHARM
41 3USL PHARMA
42 4VANGARD
43 6WARNER CHILCOTT
44 24WATSON LABS
45 2WEST WARD
46 6ZYDUS PHARMS
01 1CONCENTRATE;ORAL
02 2INJECTABLE;INJECTION
03 10TABLET; ORAL
04 281TABLET;ORAL
01 207DISCN
02 73RX
03 14Blank
01 5AMITID
02 6AMITRIL
03 202AMITRIPTYLINE HYDROCHLORIDE
04 13CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
05 7ELAVIL
06 7ENDEP
07 1ETRAFON 2-10
08 1ETRAFON 2-25
09 1ETRAFON-A
10 1ETRAFON-FORTE
11 1LIMBITROL
12 1LIMBITROL DS
13 43PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
14 1TRIAVIL 2-10
15 1TRIAVIL 2-25
16 1TRIAVIL 4-10
17 1TRIAVIL 4-25
18 1TRIAVIL 4-50
01 265No
02 15Yes
03 14Blank
RLD : No
TE Code :
Brand Name : AMITRIPTYLINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2022-06-06
Application Number : 216243
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AB
Brand Name : AMITRIPTYLINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2021-02-19
Application Number : 213999
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Brand Name : ETRAFON-A
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-01-01
Application Number : 14713
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : AMITRIPTYLINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 25MG
Approval Date : 2022-06-06
Application Number : 216243
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : AMITRIPTYLINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date : 2022-06-06
Application Number : 216243
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : AMITRIPTYLINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 75MG
Approval Date : 2022-06-06
Application Number : 216243
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : AMITRIPTYLINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 2022-06-06
Application Number : 216243
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : AMITRIPTYLINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 150MG
Approval Date : 2022-06-06
Application Number : 216243
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AB
Brand Name : AMITRIPTYLINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 25MG
Approval Date : 2021-02-19
Application Number : 213999
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AB
Brand Name : AMITRIPTYLINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date : 2021-02-19
Application Number : 213999
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
