Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEPARIN LOCK FLUSH | HEPARIN SODIUM | 100 UNITS/ML | INJECTABLE; INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 40,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 2,500 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 3,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 4,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 6,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 7,500 UNITS/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 11/22/1974 | 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 |
|---|---|---|---|---|---|
| 10/24/2024 | SUPPL-60 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017064s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017064Orig1s060ltr.pdf | |
| 01/27/1999 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1998 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/25/1996 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1994 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/08/1993 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1992 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1992 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/11/1993 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1991 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 04/23/1991 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 10/18/1991 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1991 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/16/1990 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/17/1990 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1989 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1987 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 09/14/1987 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 05/22/1987 | SUPPL-36 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/19/1986 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 04/07/1986 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/04/1985 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 05/26/1981 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/07/1978 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1978 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 07/07/1978 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/02/1978 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 06/02/1978 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/14/1978 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1977 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1977 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1977 | SUPPL-21 | Unspecified |
Label is not available on this site. |
||
| 02/24/1977 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/1977 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/24/1977 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1976 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1976 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/1976 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/12/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/24/2024 | SUPPL-60 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017064s060lbl.pdf |