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FDA Approval Activities for this Drug…
BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE Tablet, Chewable, Tablet, Capsule; 262.4MG;250MG;500MG HELIDAC Prometheus 061016 HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE Suspension/Drops; Ophthalmic 1.5%;EQ 5MG BASE/ML TERRA-CORTRIL PFIZER | 060567 LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE Injection 2%;125MG/ML TERRAMYCIN PFIZER | 060567 LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE Injection 2%;50MG/ML TERRAMYCIN PFIZER | 050286 OXYTETRACYCLINE HYDROCHLORIDE Capsule; 250MG BASE TERRAMYCIN PFIZER | 061015 OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE Ointment; Ophthalmic 5MG BASE/GM;10,000 UNITS/GM TERRAMYCIN W/ POLYMYXIN B SULFATE PFIZER | 060429 TETRACYCLINE HYDROCHLORIDE Capsule; 250MG SUMYCIN APOTHECON | 060429 TETRACYCLINE HYDROCHLORIDE Capsule; 500MG SUMYCIN APOTHECON | 060736 TETRACYCLINE HYDROCHLORIDE Capsule; 250MG TETRACYCLINE HCL AXIOM 060736 TETRACYCLINE HYDROCHLORIDE Capsule; 500MG TETRACYCLINE HCL AXIOM 061837 TETRACYCLINE HYDROCHLORIDE Capsule; 250MG TETRACYCLINE HCL Barr 061837 TETRACYCLINE HYDROCHLORIDE Capsule; 500MG TETRACYCLINE HCL Barr 061888 TETRACYCLINE HYDROCHLORIDE Capsule; 250MG BRISTACYCLINE BRISTOL | 061658 TETRACYCLINE HYDROCHLORIDE Capsule; 250MG BRISTACYCLINE BRISTOL | 061658 TETRACYCLINE HYDROCHLORIDE Capsule; 500MG BRISTACYCLINE BRISTOL | 061888 TETRACYCLINE HYDROCHLORIDE Capsule; 500MG BRISTACYCLINE BRISTOL | 060469 TETRACYCLINE HYDROCHLORIDE Capsule; 100MG TETRACYCLINE HCL Impax 060469 TETRACYCLINE HYDROCHLORIDE Capsule; 250MG TETRACYCLINE HCL Impax 060469 TETRACYCLINE HYDROCHLORIDE Capsule; 500MG TETRACYCLINE HCL Impax | 060704 TETRACYCLINE HYDROCHLORIDE Capsule; 250MG TETRACYCLINE HCL Ivax | 060704 TETRACYCLINE HYDROCHLORIDE Capsule; 500MG TETRACYCLINE HCL Ivax 062752 TETRACYCLINE HYDROCHLORIDE Capsule; 250MG TETRACYCLINE HCL ATRAL | 062752 TETRACYCLINE HYDROCHLORIDE Capsule; 500MG TETRACYCLINE HCL ATRAL | 062085 TETRACYCLINE HYDROCHLORIDE Capsule; 250MG TETRACYCLINE HCL MAST MM | 060783 TETRACYCLINE HYDROCHLORIDE Capsule; 250MG TETRACYCLINE HCL Mylan | 060783 TETRACYCLINE HYDROCHLORIDE Capsule; 500MG TETRACYCLINE HCL Mylan | 061214 TETRACYCLINE HYDROCHLORIDE Capsule; 500MG TETRACYCLINE HCL Roxane | 060400 TETRACYCLINE HYDROCHLORIDE Suspension; 125MG/5ML SUMYCIN APOTHECON | 061147 TETRACYCLINE HYDROCHLORIDE Tablet; 250MG SUMYCIN Par 061147 TETRACYCLINE HYDROCHLORIDE Tablet; 500MG SUMYCIN Par 061653 TETRACYCLINE PHOSPHATE COMPLEX Capsule; 100MG HCL TETREX BRISTOL | 061653 TETRACYCLINE PHOSPHATE COMPLEX Capsule; 250MG HCL TETREX BRISTOL | 061889 TETRACYCLINE PHOSPHATE COMPLEX Capsule; 250MG HCL TETREX BRISTOL | 061889 TETRACYCLINE PHOSPHATE COMPLEX Capsule; 500MG HCL TETREX BRISTOL | 061653 TETRACYCLINE PHOSPHATE COMPLEX Capsule; 500MG HCL TETREX BRISTOL | Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline hydrochloride), Prometheus Laboratories, Labeling Revision | Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline hydrochloride), Prometheus Laboratories, Labeling Revision | Pylera (biskalcitrate, metronidazole, and tetracycline hydrochloride) Capsules, Axcan Scandipharm, Approval | Pylera Capsules, Axcan Scandipharm, Package Change | HELIDAC Therapy, Prometheus Labs, Labeling Revision | Helidac (bismuth subsalicylate, metronidazole and tetracycline hydrochloride) Capsules, Chewable Tablets and Tablets, Prometheus Laboratories, Inc., Labeling Revision | Helidac bismuth subsalicylate; metronidazole; tetracyline hydrochloride Chewable Tablets & Capsules, Prometheus Laboratories, Labeling Revision | Pylera (bismuth subcitrate potassium, metronidazole and tetracycline) Capsules, CanReg, Inc., Labeling Revision
  
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