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PROPRANOLOL

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

InnoPran XL (propranolol hydrochloride) Extended Release Capsules, 80 and 120 mg, Reliant NDA 21-438 Propranolol Hydrochloride Injection USP, 1 mg/mL, American Pharmaceutical Partners, ANDA 76-400 2/26/03 | Propranolol Hydrochloride Injection USP, 1 mg/mL, American Pharmaceutical Partners, ANDA 75-826 8/31/01 4/15/03 | Propranolol Hydrochloride Injection USP,1 mg/mL, Bedford ANDA 75-792 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;40MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Barr | 070705 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;80MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Barr | 071060 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;40MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Geneva | 071061 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;80MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Geneva | 070946 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;40MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Mylan | 070947 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;80MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Mylan | 072042 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;40MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Pliva | 072043 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;80MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Pliva | 070851 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;40MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Purepac | 070852 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;80MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Purepac | 070301 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;40MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Watson | 070305 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;80MG PROPRANOLOL HCL AND HYDROCHLOROTHIAZIDE Watson | 018031 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;40MG INDERIDE-40/25 Wyeth INC | 018031 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE Tablet; 25MG;80MG INDERIDE-80/25 Wyeth INC | 021438 BX PROPRANOLOL HYDROCHLORIDE Capsule, Extended Release; 120MG INNOPRAN XL RELIANT 021438 BX PROPRANOLOL HYDROCHLORIDE Capsule, Extended Release; 80MG INNOPRAN XL RELIANT 018553 BX PROPRANOLOL HYDROCHLORIDE Capsule, Extended Release; 120MG INDERAL LA Wyeth INC | 018553 PROPRANOLOL HYDROCHLORIDE Capsule, Extended Release; 160MG INDERAL LA Wyeth INC | 018553 PROPRANOLOL HYDROCHLORIDE Capsule, Extended Release; 60MG INDERAL LA Wyeth INC | 018553 BX PROPRANOLOL HYDROCHLORIDE Capsule, Extended Release; 80MG INDERAL LA Wyeth INC | 071388 PROPRANOLOL HYDROCHLORIDE Concentrate; 80MG/ML PROPRANOLOL HCL INTENSOL Roxane | 016419 PROPRANOLOL HYDROCHLORIDE Injection 1MG/ML PROPRANOLOL HCL Baxter CORP | 075792 PROPRANOLOL HYDROCHLORIDE Injection 1MG/ML PROPRANOLOL HCL Bedford | 076400 PROPRANOLOL HYDROCHLORIDE Injection 1MG/ML PROPRANOLOL HCL Sabex 2002 | 070979 PROPRANOLOL HYDROCHLORIDE Solution; 20MG/5ML PROPRANOLOL HCL Roxane | 070690 PROPRANOLOL HYDROCHLORIDE Solution; 40MG/5ML PROPRANOLOL HCL Roxane | 070663 PROPRANOLOL HYDROCHLORIDE Tablet; 10MG PROPRANOLOL HCL Geneva | 070664 PROPRANOLOL HYDROCHLORIDE Tablet; 20MG PROPRANOLOL HCL Geneva | 070665 PROPRANOLOL HYDROCHLORIDE Tablet; 40MG PROPRANOLOL HCL Geneva | 070666 PROPRANOLOL HYDROCHLORIDE Tablet; 60MG PROPRANOLOL HCL Geneva | 070667 PROPRANOLOL HYDROCHLORIDE Tablet; 80MG PROPRANOLOL HCL Geneva | 070211 PROPRANOLOL HYDROCHLORIDE Tablet; 10MG PROPRANOLOL HCL Mylan | 070212 PROPRANOLOL HYDROCHLORIDE Tablet; 20MG PROPRANOLOL HCL Mylan | 070213 PROPRANOLOL HYDROCHLORIDE Tablet; 40MG PROPRANOLOL HCL Mylan | 070214 PROPRANOLOL HYDROCHLORIDE Tablet; 80MG PROPRANOLOL HCL Mylan | 070217 PROPRANOLOL HYDROCHLORIDE Tablet; 10MG PROPRANOLOL HCL Par | 070218 PROPRANOLOL HYDROCHLORIDE Tablet; 20MG PROPRANOLOL HCL Par | 070219 PROPRANOLOL HYDROCHLORIDE Tablet; 40MG PROPRANOLOL HCL Par | 070220 PROPRANOLOL HYDROCHLORIDE Tablet; 60MG PROPRANOLOL HCL Par | 070221 PROPRANOLOL HYDROCHLORIDE Tablet; 80MG PROPRANOLOL HCL Par | 071288 PROPRANOLOL HYDROCHLORIDE Tablet; 90MG PROPRANOLOL HCL Par | 071972 PROPRANOLOL HYDROCHLORIDE Tablet; 10MG PROPRANOLOL HCL Pliva | 071973 PROPRANOLOL HYDROCHLORIDE Tablet; 20MG PROPRANOLOL HCL Pliva | 071974 PROPRANOLOL HYDROCHLORIDE Tablet; 40MG PROPRANOLOL HCL Pliva | 071975 PROPRANOLOL HYDROCHLORIDE Tablet; 60MG PROPRANOLOL HCL Pliva | 071976 PROPRANOLOL HYDROCHLORIDE Tablet; 80MG PROPRANOLOL HCL Pliva | 071977 PROPRANOLOL HYDROCHLORIDE Tablet; 90MG PROPRANOLOL HCL Pliva | 070234 PROPRANOLOL HYDROCHLORIDE Tablet; 40MG PROPRANOLOL HCL Teva | 070175 PROPRANOLOL HYDROCHLORIDE Tablet; 10MG PROPRANOLOL HCL Watson | 070548 PROPRANOLOL HYDROCHLORIDE Tablet; 10MG PROPRANOLOL HCL Watson | 070176 PROPRANOLOL HYDROCHLORIDE Tablet; 20MG PROPRANOLOL HCL Watson | 070177 PROPRANOLOL HYDROCHLORIDE Tablet; 40MG PROPRANOLOL HCL Watson | 070550 PROPRANOLOL HYDROCHLORIDE Tablet; 40MG PROPRANOLOL HCL Watson | 071791 PROPRANOLOL HYDROCHLORIDE Tablet; 60MG PROPRANOLOL HCL Watson | 070551 PROPRANOLOL HYDROCHLORIDE Tablet; 80MG PROPRANOLOL HCL Watson | 070178 PROPRANOLOL HYDROCHLORIDE Tablet; 80MG PROPRANOLOL HCL Watson | 071792 PROPRANOLOL HYDROCHLORIDE Tablet; 90MG PROPRANOLOL HCL Watson | 016418 PROPRANOLOL HYDROCHLORIDE Tablet; 10MG INDERAL Wyeth INC | 016418 PROPRANOLOL HYDROCHLORIDE Tablet; 20MG INDERAL Wyeth INC | 016418 PROPRANOLOL HYDROCHLORIDE Tablet; 40MG INDERAL Wyeth INC | 016418 PROPRANOLOL HYDROCHLORIDE Tablet; 60MG INDERAL Wyeth INC | 016418 PROPRANOLOL HYDROCHLORIDE Tablet; 80MG INDERAL Wyeth INC Inderal (propranolol hydrochloride)LA Capsules, Wyeth Pharmaceuticals Inderide (propranolol hydrochloride and hydrochlorothiazide) Tablets, Ayerst Laboratories Inderal (propranolol hydrochloride) Tablets, Wyeth Pharmaceuticals, Labeling Revision | InnoPran XL (propranolol hydrochloride) Extended Release Capsules, Reliant, Labeling Revision | Inderal (propranolol hydrochloride) Injection, Baxter HealthCare Corp., Labeling Revision | Inderide (propranolol hydrochloride and hydrochlorothiazide) Tablets, Wyeth Pharma, Labeling Revision | Inderal LA (propranolol hydrochloride) Long-Acting Capsules, Wyeth Pharma, Labeling Revision | Propranolol Hydrochloride Extended-Release Capsules, Par Pharma, Approval | Propranolol Hydrochloride Extended-release Capsules, Mylan Pharma, Approval | Inderal LA (propranolol hydrochloride) Long-Acting Capsules, Wyeth Pharma, Labeling Revision | Inderal (propranolol hydrochloride) Tablets, Wyeth Pharma, Labeling Revision | Inderide (propranolol hydrochloride) Tablets Wyeth Pharma, Labeling Revision | Propranolol Hydochloride, Extended-release Capsules, Actavis, Approval | Inderal (propranolol hydrochloride) Tablets, Wyeth Pharma, Labeling Revision | Inderal LA Capsules, Wyeth Pharma, Labeling Revision | Innopran XL (propranolol hydrochloride) Extended-Release Capsules, Reliant Pharma, Labeling Revision | Inderide (propranolol hydrochloride and hydrochlorothiazide) Tablets, Wyeth Pharma, Labeling Revision | Propranolol Hydrochloride Tablets, Northstar, Approval | Propranolol Hydrochloride Injection, Hikma Farmaceutica, Approval | Inderal (propranolol hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision | Propranolol Hydrochloride Tablets, Ipca Laboratories, Ltd., Approval | Propranolol Hydochloride Extended-Release Capsules, Upsher-Smith Laboratories, Inc., Approval | Innopran XL (propranolol hydrochloride) Extended Release Capsules, GlaxoSmithKline, Labeling Revision | Inderide-40/25 (hydrochlorothiazide and propranolol hydrochloride) Tablets, Akrimax Pharmaceuticals, LLC, Labeling Revision | Inderide-80/25 (hydrochlorothiazide and propranolol hydrochloride) Tablets, Akrimax Pharmaceuticals, LLC, Labeling Revision | Innopran XL (propranolol hydrochloride) Extended-Release Capsules, GlaxoSmithKline, Labeling Revision | Propranolol Hydrochloride Extended-Release Capsules, Zydus Pharmaceuticals (USA), Inc., Approval | Inderal (propranolol hydrochloride) Tablets, Akrimax Pharmaceuticals, Labeling Revision | Inderal LA (propranolol hydrochloride) Extended-Release Capsules, Akrimax Pharmaceuticals, Labeling Revision | Inderide (propranolol hydrochloride and hydrochlorothiazide) Tablets, Akrimax Pharmaceuticals, Labeling Revision | Propranolol Hydrochloride Extended-Release Capsules, GlaxoSmithKline, Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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