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01 3Allergan Aesthetics
02 7LGM Pharma
03 4Dr. Reddy's Laboratories
04 8Mikart
05 9Strides 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 2Forest Laboratories
17 1Fosun Pharmaceutical
18 2HALSEY
19 9Hikma Pharmaceuticals
20 1IVAX Pharmaceuticals Inc
21 1Jerome Stevens Pharmaceuticals
22 1Key Therapeutics
23 1LABORATOIRE RIVA INC.
24 2LARKEN LABS
25 2Laboratoires Gilbert
26 4Lannett Company, Inc.
27 1MAYRAND
28 9Mallinckrodt Pharmaceuticals
29 1Mirror Pharmaceuticals LLC
30 1NRx Pharmaceuticals
31 1Nesher Pharmaceuticals USA LLC
32 1Novast Laboratories
33 1Novitium Pharma LLC
34 1Nuvo Pharmaceuticals
35 1PURACAP PHARM
36 5Quagen Pharma
37 1Quantum Pharma
38 1SHIRE PLC
39 1Sandoz B2B
40 1Savage Lab
41 5Senores Pharmaceuticals
42 5Sun Pharmaceutical Industries Limited
43 1Taro Pharmaceutical Industries
44 4Teva Pharmaceutical Industries
45 1The Medicines Patent Pool
46 1US CHEM
47 1Vintage Pharmaceuticals-Charlotte
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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 5Tablet
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01 5CONTROLLED DRUGS (CDSA IV)
02 64DISCN
03 6NARCOTICS (CDSA I)
04 48RX
05 8Blank
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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 1Aspirin; Butalbital; Caffeine
09 1Aspirin; Butalbital; Caffeine; Codeine Phosphate
10 1BANCAP
11 1BUCET
12 15BUTALBITAL AND ACETAMINOPHEN
13 47BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
14 8BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
15 12BUTALBITAL, ASPIRIN AND CAFFEINE
16 5BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
17 1BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
18 2BUTAPAP
19 1Butalbital; Paracetamol; Caffeine
20 1ESGIC
21 2ESGIC-PLUS
22 1FEMCET
23 1FIORICET W/ CODEINE
24 3FIORINAL
25 1FIORINAL W/CODEINE
26 1FIORINAL-C 1/2
27 1FIORINAL-C 1/4
28 2LANORINAL
29 1MEDIGESIC PLUS
30 1PHRENILIN
31 1PHRENILIN FORTE
32 1PHRENILIN WITH CAFFEINE AND CODEINE
33 1Paracetamol; Butalbital; Caffeine
34 1Paracetamol; Butalbital; Caffeine; Codeine Phosphate
35 1SEDAPAP
36 1TENCON
37 2TEVA-TECNAL
38 1TEVA-TECNAL C 1/2
39 1TEVA-TECNAL C 1/4
40 1TRIAD
41 1TRIANAL TABLET
42 1TRIAPRIN
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01 11Canada
02 7India
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
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
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
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
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
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