Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | AP | Yes | Yes |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;INJECTION | Prescription | AP | Yes | Yes |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 270MG/30ML (9MG/ML) | SOLUTION;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/29/1982 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/06/2017 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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06/12/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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02/12/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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02/19/2003 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18800slr014ltr.pdf |
09/30/1997 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/16/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
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08/29/1996 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/21/1988 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/22/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/15/1985 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/25/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/17/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/14/1984 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/25/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
SOLUTION;INJECTION; 90MG/10ML (9MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 088911 | FRESENIUS KABI USA |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 018800 | HOSPIRA |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 201833 | HIKMA |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 217535 | NEXUS PHARMS |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 206171 | SPECTRA MDCL DEVICES |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 088912 | FRESENIUS KABI USA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 018803 | HOSPIRA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 077407 | TARO |
SOLUTION;INJECTION; 180MG/20ML (9MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 018800 | HOSPIRA |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 217535 | NEXUS PHARMS |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 088912 | FRESENIUS KABI USA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 018803 | HOSPIRA |
SOLUTION;INJECTION; 270MG/30ML (9MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 270MG/30ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 088911 | FRESENIUS KABI USA |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 270MG/30ML (9MG/ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 018800 | HOSPIRA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 270MG/30ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 088912 | FRESENIUS KABI USA |