Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070755
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHIUM CITRATE LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP;ORAL Prescription AA 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
05/21/1986 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2008 SUPPL-13 Labeling

Label is not available on this site.

04/22/1997 SUPPL-9 Labeling

Label is not available on this site.

02/05/1996 SUPPL-8 Labeling

Label is not available on this site.

08/12/1994 SUPPL-7 Labeling

Label is not available on this site.

08/29/1990 SUPPL-6 Labeling

Label is not available on this site.

03/27/1989 SUPPL-5 Labeling

Label is not available on this site.

03/25/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/25/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/17/1987 SUPPL-2 Labeling

Label is not available on this site.

11/10/1986 SUPPL-1 Labeling

Label is not available on this site.

LITHIUM CITRATE

SYRUP;ORAL; EQ 300MG CARBONATE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LITHIUM CITRATE LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP;ORAL Prescription Yes AA 018421 HIKMA
LITHIUM CITRATE LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP;ORAL Prescription No AA 070755 WOCKHARDT BIO AG

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