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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

For the latest approval information, please see the main page.

 
 
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