Details for New Drug Application (NDA): 017377
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The generic ingredient in BACTRIM DS is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.
Summary for 017377
Tradename: | BACTRIM DS |
Applicant: | Sun Pharm Industries |
Ingredient: | sulfamethoxazole; trimethoprim |
Patents: | 0 |
Suppliers and Packaging for NDA: 017377
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACTRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017377 | NDA | Sun Pharmaceutical Industries, Inc | 49708-145 | 49708-145-01 | 100 TABLET in 1 BOTTLE, PLASTIC (49708-145-01) |
BACTRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017377 | NDA | Sun Pharmaceutical Industries, Inc | 49708-146 | 49708-146-01 | 100 TABLET in 1 BOTTLE, PLASTIC (49708-146-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG;80MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG;160MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 017377
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sun Pharm Industries | BACTRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017377-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Sun Pharm Industries | BACTRIM DS | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017377-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
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