01 3Allergan Aesthetics
02 7LGM Pharma
03 4Dr. Reddy's Laboratories
04 8Mikart
05 5Strides Pharma Science
06 5Granules India Limited
07 1ABHAI LLC
08 1AVIV PHARMA
09 9Actavis Inc
10 3Alvogen
11 3Apotex Inc
12 3Aralez Pharmaceuticals
13 1Aurolife Pharma LLC
14 3Bausch Health
15 1DUNHALL
16 1Esjay Pharma
17 2Forest Laboratories
18 1Fosun Pharmaceutical
19 2HALSEY
20 9Hikma Pharmaceuticals
21 1IVAX Pharmaceuticals Inc
22 1Jerome Stevens Pharmaceuticals
23 1Key Therapeutics
24 1LABORATOIRE RIVA INC.
25 2LARKEN LABS
26 2Laboratoires Gilbert
27 4Lannett Company, Inc.
28 1MAYRAND
29 1MPP PHARMA
30 9Mallinckrodt Pharmaceuticals
31 1Mirror Pharmaceuticals LLC
32 1NRx Pharmaceuticals
33 1Nesher Pharmaceuticals USA LLC
34 1Novast Laboratories
35 1Nuvo Pharmaceuticals
36 1PURACAP PHARM
37 5Quagen Pharma
38 1Quantum Pharma
39 1SHIRE PLC
40 1Sandoz B2B
41 1Savage Lab
42 5Senores Pharmaceuticals
43 5Sun Pharmaceutical Industries Limited
44 1Taro Pharmaceutical Industries
45 4Teva Pharmaceutical Industries
46 1US CHEM
47 1Vintage Pharmaceuticals-Charlotte
01 9CAPSULE
02 56CAPSULE;ORAL
03 1Capsule; Oral
04 1Immediate Release Capsule
05 1Immediate Release Tablet
06 1SOLUTION;ORAL
07 2TABLET
08 55TABLET;ORAL
09 1Tablet
01 64DISCN
02 48RX
03 15Blank
01 1ALLZITAL
02 1ANOQUAN
03 1APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE
04 1APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/2
05 1APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4
06 1AXOTAL
07 2Acetaminophen ; Butalbital ; Caffeine
08 1BANCAP
09 1BUCET
10 15BUTALBITAL AND ACETAMINOPHEN
11 47BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
12 8BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
13 12BUTALBITAL, ASPIRIN AND CAFFEINE
14 5BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
15 1BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
16 2BUTAPAP
17 1Butalbital; Paracetamol; Caffeine
18 1ESGIC
19 2ESGIC-PLUS
20 1FEMCET
21 1FIORICET W/ CODEINE
22 3FIORINAL
23 1FIORINAL W/CODEINE
24 1FIORINAL-C 1/2
25 1FIORINAL-C 1/4
26 2LANORINAL
27 1MEDIGESIC PLUS
28 1PHRENILIN
29 1PHRENILIN FORTE
30 1PHRENILIN WITH CAFFEINE AND CODEINE
31 1SEDAPAP
32 1TENCON
33 2TEVA-TECNAL
34 1TEVA-TECNAL C 1/2
35 1TEVA-TECNAL C 1/4
36 1TRIAD
37 1TRIANAL TABLET
38 1TRIAPRIN
01 11Canada
02 3India
03 113USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FIORINAL
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1986-04-16
Application Number : 17534
Regulatory Info : DISCN
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG;50MG;40MG
Packaging :
Approval Date : 2009-11-16
Application Number : 40885
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 1986-03-17
Application Number : 89007
Regulatory Info : RX
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : ESGIC-PLUS
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG;50MG;40MG
Packaging :
Approval Date : 1996-03-28
Application Number : 40085
Regulatory Info : DISCN
Registration Country : USA
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2003-08-27
Application Number : 40511
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2008-12-01
Application Number : 40864
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FIORINAL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1986-04-16
Application Number : 17534
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : FIORINAL W/CODEINE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG;30MG
Packaging :
Approval Date : 1990-10-26
Application Number : 19429
Regulatory Info : DISCN
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG;30MG
Packaging :
Approval Date : 2001-11-30
Application Number : 75231
Regulatory Info : RX
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG;30MG
Packaging :
Approval Date : 2004-06-10
Application Number : 76560
Regulatory Info : RX
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG;50MG;40MG;30MG
Packaging :
Approval Date : 2012-07-19
Application Number : 76560
Regulatory Info : RX
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
Brand Name : BUTALBITAL AND ACETAMINOPHEN
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG;50MG
Packaging :
Approval Date : 2011-08-23
Application Number : 90956
Regulatory Info : RX
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BUTALBITAL, ASPIRIN AND CAFFEINE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG;50MG;40MG
Packaging :
Approval Date : 2021-10-18
Application Number : 205230
Regulatory Info : DISCN
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2018-10-31
Application Number : 209587
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : DISCN
Registration Country : USA
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG;30MG
Packaging :
Approval Date : 2015-10-30
Application Number : 203335
Regulatory Info : DISCN
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : BUTALBITAL AND ACETAMINOPHEN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG;50MG
Packaging :
Approval Date : 2017-12-27
Application Number : 207313
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG;50MG;40MG
Packaging :
Approval Date : 2019-12-17
Application Number : 210817
Regulatory Info : RX
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 325MG/15ML;50MG/15ML;40MG/15ML
Packaging :
Approval Date : 2003-01-31
Application Number : 40387
Regulatory Info : RX
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 750MG;50MG;40MG
Packaging :
Approval Date : 2003-12-23
Application Number : 40496
Regulatory Info : DISCN
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 1987-01-21
Application Number : 89175
Regulatory Info : RX
Registration Country : USA
