Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENICILLIN G SODIUM | PENICILLIN G SODIUM | 5,000,000 UNITS/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/13/1988 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063014Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/08/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/06/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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01/27/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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01/13/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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12/02/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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11/17/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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02/03/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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01/23/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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02/03/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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12/14/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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12/07/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |